The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Spetzler Pin.
Device ID | K945639 |
510k Number | K945639 |
Device Name: | SPETZLER PIN |
Classification | Pin, Fixation, Smooth |
Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert E Smith |
Correspondent | Robert E Smith HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-16 |
Decision Date | 1995-04-14 |