STAINLESS STEEL SOFT SUTURE WIRE
FDA 510(k) clearance K990355 · decided 1999-07-08
Clearance details
- K-number
- K990355
- Device name
- STAINLESS STEEL SOFT SUTURE WIRE
- Applicant
- Bregma International Trading Company , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-05
- Decision date
- 1999-07-08
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- LRN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Saskatoon, Saskatchewan, CA
- 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 |
|---|---|---|
| NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE (K002755) | T. Korossurgical Instruments Corp. | 2000-12-04 |
| J-FX CERCLAGE SYSTEM (K971682) | Johnson & Johnson Professionals, Inc. | 1997-06-27 |
| OXBORO-MEDICAL PIN COVERS (K952783) | Oxboro Medical Intl., Inc. | 1995-09-15 |
| ORTHOPAEDIC WIRES (K942603) | Acu Med, Inc. | 1994-11-09 |
| TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (K900926) | Howmedica Corp. | 1990-04-23 |
| SONGER WIRING SYSTEM (K892651) | Danek Medical, Inc. | 1989-07-25 |
| TYPE 316L COTTER WIRE (K864375) | Winn Hirsch & Assoc. | 1987-05-20 |
Recalls involving this device
No recalls on record reference this clearance.