The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modified Long Length Gamma Nail.
| Device ID | K993670 |
| 510k Number | K993670 |
| Device Name: | MODIFIED LONG LENGTH GAMMA NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Margaret Crowe |
| Correspondent | Margaret Crowe 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 | 1999-11-01 |
| Decision Date | 1999-11-16 |
| Summary: | summary |