RBM
FDA 510(k) clearance K020480 · decided 2002-03-12
Clearance details
- K-number
- K020480
- Device name
- RBM
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-13
- Decision date
- 2002-03-12
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- KGS
- Device class
- 1
- Regulation number
- 878.4930
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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| ACUFEX FIXATION BUTTON (K884565) | Acufex Microsurgical, Inc. | 1989-02-27 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FAST-FIX AB Curved Needle Delivery System, Used for meniscal repair. Product Number: 72093 recall (Z-0798-06) | Smith & Nephew, Inc. Endoscopy Division | 2006-04-26 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |