The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Motech Moss-miami Spinal System.
Device ID | K933881 |
510k Number | K933881 |
Device Name: | DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Contact | Cheryl Hastings |
Correspondent | Cheryl Hastings DEPUY, INC. P.O. BOX 988 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-10 |
Decision Date | 1994-07-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705034020426 | K933881 | 000 |
10705034020389 | K933881 | 000 |
10705034020419 | K933881 | 000 |
10705034020433 | K933881 | 000 |
10705034020440 | K933881 | 000 |
10705034020525 | K933881 | 000 |
10705034019871 | K933881 | 000 |
10705034019475 | K933881 | 000 |
10705034019482 | K933881 | 000 |
10705034020365 | K933881 | 000 |
10705034020402 | K933881 | 000 |
10705034020228 | K933881 | 000 |