The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Titanium Moss Miami Spinal System.
| Device ID | K955348 |
| 510k Number | K955348 |
| Device Name: | 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-21 |
| Decision Date | 1996-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034034126 | K955348 | 000 |
| 10705034034102 | K955348 | 000 |
| 10705034034010 | K955348 | 000 |
| 10705034033495 | K955348 | 000 |
| 10705034033488 | K955348 | 000 |
| 10705034034089 | K955348 | 000 |