The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Codman Anterior Cervical Plate System.
Device ID | K953730 |
510k Number | K953730 |
Device Name: | CODMAN ANTERIOR CERVICAL PLATE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
Contact | Amy Walters |
Correspondent | Amy Walters JOHNSON & JOHNSON PROFESSIONALS, INC. ROUTE 202 N. Raritan, NJ 08869 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-10 |
Decision Date | 1995-11-09 |