Awl
FDA product code HWJ · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
4510(k) clearances
0PMA approvals
26recalls
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K895587 | Cross Medical Product Pedicle AwlHWJ · Traditional | Cross Medical Products, Inc. | 01/04/1990SE |
| K880045 | Acromed Awl/Punch, Depth GaugeHWJ · Traditional | Buckman Co., Inc. | 02/17/1988SE |
| K875223 | Danninger Orthopaedic AwlHWJ · Traditional | Danninger Medical Technology, Inc. | 02/17/1988SE |
| K870779 | Acromed Wallie-Heinig TrocharHWJ · Traditional | Buckman Co., Inc. | 03/09/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2357-2024 Class II | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog…Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. | Seaspine Orthopedics Corporation | 06/04/2024Open, Classified |
| Z-2475-2023 Class II | LIF AMP, Adjustable Awl, REF 117-165, Part of the AMP System. Used with Spine Lateral…Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking… | Alphatec Spine, Inc. | 07/07/2023Open, Classified |
| Z-2031-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2030-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2029-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2028-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2027-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2026-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2025-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2024-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2023-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2022-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2021-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2020-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2019-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2018-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2017-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2016-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2015-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2014-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2013-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2012-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2011-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2010-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2009-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |
| Z-2008-2020 Class II | K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel…The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has… | K2M, Inc | 04/13/2020Terminated |