The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Motech Titanium Moss Miami Spinal System.
| Device ID | K964024 |
| 510k Number | K964024 |
| Device Name: | DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Cheryl Hastings |
| Correspondent | Cheryl Hastings DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034034218 | K964024 | 000 |
| 10705034034256 | K964024 | 000 |
| 10705034034249 | K964024 | 000 |
| 10705034034225 | K964024 | 000 |