The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Wichita Fusion Nail Fully Threaded Self-tapping Screw.
| Device ID | K993603 |
| 510k Number | K993603 |
| Device Name: | WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Jennifer A Daudelin |
| Correspondent | Jennifer A Daudelin HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-25 |
| Decision Date | 1999-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327050189 | K993603 | 000 |
| 07613327050172 | K993603 | 000 |
| 07613327050165 | K993603 | 000 |
| 07613327050158 | K993603 | 000 |
| 07613327050141 | K993603 | 000 |
| 07613327050134 | K993603 | 000 |
| 07613327050127 | K993603 | 000 |
| 07613327050110 | K993603 | 000 |