The following data is part of a premarket notification filed by Sofamor Danek Usa,inc. with the FDA for Cd Liberty Posterior Spincal System.
Device ID | K951164 |
510k Number | K951164 |
Device Name: | CD LIBERTY POSTERIOR SPINCAL SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Contact | Richard W Treharne |
Correspondent | Richard W Treharne SOFAMOR DANEK USA,INC. 1800 PYRAMID PLACE Memphis, TN 38132 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-14 |
Decision Date | 1996-02-09 |