SELF RETAINING SOFT TISSUE RETRACTOR
FDA 510(k) clearance K101609 · decided 2010-12-09
Clearance details
- K-number
- K101609
- Device name
- SELF RETAINING SOFT TISSUE RETRACTOR
- Applicant
- Koros USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-08
- Decision date
- 2010-12-09
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- LXH
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Moorepark, CA, 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 |
|---|---|---|
| SX-One MicroKnife (K192873) | Sonex Health, Inc. | 2019-12-20 |
| IMBIBE NEEDLE (K140414) | Orthovita, Inc. | 2014-04-01 |
| MICROPERFORATION INSTRUMENT (K001507) | Smith & Nephew, Inc. | 2000-06-14 |
| 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.