The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Bridgepoint Spinous Process Camp- Posterior Fixation System.
Device ID | K103205 |
510k Number | K103205 |
Device Name: | BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
Applicant | ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
Contact | Olga Lewis |
Correspondent | Olga Lewis ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
Product Code | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-01 |
Decision Date | 2011-06-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00844856059191 | K103205 | 000 |
00844856059184 | K103205 | 000 |
00844856059177 | K103205 | 000 |