REPOSE BONE SCREW SYSTEM
FDA 510(k) clearance K981677 · decided 1999-08-27
Clearance details
- K-number
- K981677
- Device name
- REPOSE BONE SCREW SYSTEM
- Applicant
- Influence, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-12
- Decision date
- 1999-08-27
- Days to decision
- 472 days
- Clearance type
- Traditional
- Product code
- LRK
- Device class
- 2
- Regulation number
- 872.5570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Influence
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SnØreNegatØr (K261912) | DnB Innovations, LLC | 2026-07-31 |
| Virtus (K261366) | Somnomed, Inc. | 2026-06-12 |
| Snorbliss® Anti-Snoring Device (K261251) | Endeavor Commerce, LLC | 2026-06-11 |
| Dormiva Anti-Snoring Mouth Guard (K261134) | Koncept Innovators, Inc. | 2026-05-14 |
| ShaeferH (K252942) | Shaeferh, LLC | 2026-04-10 |
| Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) (K253845) | Ram.Shaw Pte. , Ltd. | 2026-03-03 |
| Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) (K252531) | Myofunctional Research Co. | 2026-03-02 |
| Park Dental Nylon MAD (K252976) | Park Dental Research Corp. | 2025-12-18 |
| QuietLab Pro (K253868) | QuietLab, LLC | 2025-12-05 |
| Hushd Avera (K252161) | Good Sleep CO Pte , Ltd. | 2025-11-25 |
| AIO Breathe (K252525) | Aiomega, LLC | 2025-11-06 |
| NightGuard Aire Max (K252698) | Nightguard Express, LLC | 2025-11-03 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtron recall (Z-0535-2010) | Medtronic Xomed, Inc. | 2009-12-15 |
| Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200. Distributed by Medtronic Xome recall (Z-0536-2010) | Medtronic Xomed, Inc. | 2009-12-15 |