Brace, Drill
FDA product code HXY · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
7510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923776 | Benderev Drill GuideHXY · Traditional | Neimark Labs, Inc. | 11/06/1992SE |
| K892904 | Mitek Drill GuideHXY · Traditional | Mitek Surgical Products, Inc. | 09/28/1989SE |
| K880264 | Bone Suture Fixation DeviceHXY · Traditional | Orthopedic Systems, Inc. | 03/23/1988SN |
| K880381 | Telos Distal Targeting DeviceHXY · Traditional | Austin Assoc. | 03/15/1988SE |
| K880046 | Hasting Finger Fixator InstrumentsHXY · Traditional | Buckman Co., Inc. | 02/16/1988SE |
| K831043 | Andrews Remote Chuck DrillHXY · Traditional | Orthopedic Systems, Inc. | 04/28/1983SE |
| K770204 | Cement Extractor DrillHXY · Traditional | Depuy, Inc. | 02/08/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2075-2015 Class II | Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical Instruments are…Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are… | Musculoskeletal Transplant Foundation, Inc. | 05/27/2015Terminated |