Accessories, Fixation, Spinal Intervertebral Body
FDA product code LYQ · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
3510(k) clearances
0PMA approvals
2recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K893415 | Trans-Oral Depth GaugeLYQ · Traditional | Ruggles Corp. | 06/07/1989SE |
| K883784 | TSRH Anterior Spinal Screws, Staples and End PlateLYQ · Traditional | Warsaw Orthopedic, Inc. | 04/06/1989SN |
| K882871 | Casf Drill Guide DG 170LYQ · Traditional | Terray Manufacturing, Inc. | 09/23/1988SN |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2318-2017 Class II | Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting…Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque… | Zimmer Biomet Spine Inc. | 05/10/2017Terminated |
| Z-1057-2015 Class II | KYPHON EXPRESS, Osteo Introducer System, Diamond and Bevel, Size 2, REF T34A, QTY: 1EA…The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may… | Medtronic Sofamor Danek USA Inc | 01/13/2015Terminated |