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 |