The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Moss Miami Spinal System.
Device ID | K962628 |
510k Number | K962628 |
Device Name: | MOSS MIAMI SPINAL SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
Contact | Cheryl Hastings |
Correspondent | Cheryl Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. 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 | 1996-07-05 |
Decision Date | 1997-03-18 |
Summary: | summary |