The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Modification To: Long Length Gamma Nail.
| Device ID | K012158 |
| 510k Number | K012158 |
| Device Name: | MODIFICATION TO: LONG LENGTH GAMMA NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-11 |
| Decision Date | 2001-08-01 |
| Summary: | summary |