MEMOGRAPH STAPLE, WARM SYSTEM
FDA 510(k) clearance K993714 · decided 2000-02-25
Clearance details
- K-number
- K993714
- Device name
- MEMOGRAPH STAPLE, WARM SYSTEM
- Applicant
- Biomedical Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-02
- Decision date
- 2000-02-25
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- JDR
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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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.