MICROPERFORATION INSTRUMENT
FDA 510(k) clearance K001507 · decided 2000-06-14
Clearance details
- K-number
- K001507
- Device name
- MICROPERFORATION INSTRUMENT
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-15
- Decision date
- 2000-06-14
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- LXH
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| IMBIBE NEEDLE (K140414) | Orthovita, Inc. | 2014-04-01 |
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| ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (K952495) | Orthopedic Systems, Inc. | 1996-01-22 |
| ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (K943873) | Orthomet, Inc. | 1995-04-26 |
| SPINAL MARKER (K944188) | Leibinger L.P. | 1995-04-13 |
| STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (K941896) | Depuy, Inc. | 1994-11-07 |
| HYPERFLEX FLEXIBLE GUIDEWIRES (K941711) | Linvatec Corp. | 1994-08-26 |
| STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (K941605) | Stryker Corp. | 1994-08-05 |
| PUNCH SURGICAL (K933772) | Mahe-Medizintechnik | 1994-02-01 |
| SOFAMOR ORTHOPAEDIC INSTRUMENTS (K933242) | Danek Medical, Inc. | 1994-01-28 |
| BARRIER BONE WAX APPLICATOR (K934260) | Phillips Pharmaceuticals, Inc. | 1994-01-26 |
Recalls involving this device
No recalls on record reference this clearance.
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 |