The following data is part of a premarket notification filed by Pfizer Hospital Products Group, Inc. with the FDA for Mega Plus Super Lag Screw.
Device ID | K930156 |
510k Number | K930156 |
Device Name: | MEGA PLUS SUPER LAG SCREW |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Contact | Robert E Smith |
Correspondent | Robert E Smith PFIZER HOSPITAL PRODUCTS GROUP, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-13 |
Decision Date | 1994-02-22 |