LACTOSORB POP RIVET
FDA 510(k) clearance K981798 · decided 1998-07-13
Clearance details
- K-number
- K981798
- Device name
- LACTOSORB POP RIVET
- Applicant
- Biomet, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-21
- Decision date
- 1998-07-13
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- JDR
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biomet
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 |
|---|---|---|
| Megalodon Dynamic Compression System (K261121) | Paragon 28, Inc. | 2026-08-06 |
| Linkt Compression Staple System (K250712) | Trax Surgical | 2025-05-14 |
| Medline UNITE® REFLEX® Hybrid Nitinol Implant System (K243888) | Medline Industries, LP | 2025-04-11 |
| Arthrex DynaNite Nitinol Staples (K243742) | Arthrex, Inc. | 2025-01-31 |
| TMC Compression Implant System (K243658) | Treace Medical Concepts | 2024-12-26 |
| TMC Compression Implant System (K242415) | Treace Medical Concepts | 2024-09-06 |
| COGNiTiON™ Staple System (K240212) | Ortho Solutions UK , Ltd. | 2024-02-23 |
| A’TOMIC™ Nitinol Fixation System (K232990) | Rmr Ortho, LLC | 2024-01-12 |
| arcad® 2.0 Duo & Quadro osteosynthesis compressive staples (K230724) | Novastep | 2023-12-04 |
| Medline UNITE® REFLEX® Nitinol Staple Kit (K232905) | Medline Industries, LP | 2023-10-19 |
| StealthFix Intraosseous Fixation System (K232324) | Medartis, Inc. | 2023-08-30 |
| Treace Medical Concepts (TMC) Compression Implant System (K232387) | Treace Medical Concepts | 2023-08-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| C2A-TAPER ACETABULAR HIP SYSTEM (P050009/S009) | Biomet, Inc. | 2011-02-11 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S004) | Biomet, Inc. | 2009-04-17 |
| C2A TAPER ACETABULAR SYSTEM (P050009/S007) | Biomet, Inc. | 2009-03-13 |
| C2-A TAPER ACETABULAR SYSTEM (P050009/S005) | Biomet, Inc. | 2007-11-30 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S002) | Biomet, Inc. | 2006-06-16 |
| C2A-TAPER ACETABULAR SYSTEM (P050009/S001) | Biomet, Inc. | 2006-02-01 |
| C2 A-TAPER ACETABULAR SYSTEM (P050009) | Biomet, Inc. | 2005-12-16 |