ORTHOCORD SUTURE
FDA 510(k) clearance K040004 · decided 2004-04-13
Clearance details
- K-number
- K040004
- Device name
- ORTHOCORD SUTURE
- Applicant
- Depuy Mitek
- Decision
- Substantially Equivalent
- Date received
- 2004-01-02
- Decision date
- 2004-04-13
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Norwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Orthocord Suture, DePuy Mitek, a Johnson & Johnson Company; . DePuy Mitek, Inc. 325 Paramo recall (Z-1316-2009) | Ethicon, Inc. | 2009-05-12 |