Gauge, Depth
FDA product code HTJ · Class I (low risk) · 21 CFR 888.4300 · Orthopedic
4510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940480 | Acufex Sub-Acromial Space Measuring DeviceHTJ · Traditional | Acufex Microsurgical, Inc. | 03/23/1994SE |
| K925335 | Acufex Intra Articular Measuring DeviceHTJ · Traditional | Acufex Microsurgical, Inc. | 12/29/1992SE |
| K873191 | Acromed Interbody Depth GaugesHTJ · Traditional | Buckman Co., Inc. | 09/09/1987SE |
| K864426 | Raylor(Tm) Depth GaugeHTJ · Traditional | Cedar Surgical, Inc. | 11/26/1986SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1947-2019 Class II | DVR Crosslock ePAK Depth Gauge, Model Number 212000003 Product Usage: These DVR Express…There is a potential for weak seals of the sterile packaging. | Zimmer Biomet, Inc. | 05/28/2019Terminated |
| Z-1862-2011 | Xcelerate Specialty Patella Milling System Per File K2399; Catalog Number I-K2399PR00…Stryker Orthopaedics has become aware that the 10 mm on the bone remaining depth gage is incorrect thus… | Stryker Howmedica Osteonics Corp. | 01/27/2011Terminated |
| Z-0796-2010 | Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in…The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings. | Stryker Howmedica Osteonics Corp. | 12/22/2009Terminated |