The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Gamma Locking Nail Modification.
| Device ID | K940286 |
| 510k Number | K940286 |
| Device Name: | GAMMA LOCKING NAIL MODIFICATION |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | Robert E Smith |
| Correspondent | Robert E Smith HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-10 |
| Decision Date | 1994-03-14 |