The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Bosworth Coraco-clavicular Screw.
| Device ID | K023294 |
| 510k Number | K023294 |
| Device Name: | BOSWORTH CORACO-CLAVICULAR SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-02 |
| Decision Date | 2002-10-09 |
| Summary: | summary |