510(k) K043298 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
BLUE ORTHOCORD SUTURE
| Applicant | Depuy Mitek, Norwood MA, US |
| Decision | Substantially Equivalent, Dec 10, 2004 |
| Received | Nov 30, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043298
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. Terminated |
NEW | None listed |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. Terminated |
NEW | None listed |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedu Terminated |
NEW | None listed |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115.
For use in general soft tissue approximation, and/or ligation, including orthopedic procedur Terminated |
NEW | None listed |
| Apr 25, 2013 | DePuy Mitek, Inc., a Johnson & Johnson Co. ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116.
For use in general soft tissue approximation, and/or ligation, including orthopedi Terminated |
NEW | None listed |
| May 12, 2009 | Ethicon, Inc. Orthocord Blue Braided Composite Suture, DePuy Mitek, A Johnson & Johnson Company, Meets USP and EP, except for diameter.
DePuy Mitek, Inc.
325 Paramount Drive, Raynham, MA 02767
Sutures are intended Terminated |
NEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.