The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Alphatec Spine Anterior Lumbar Plating System.
| Device ID | K101255 |
| 510k Number | K101255 |
| Device Name: | ALPHATEC SPINE ANTERIOR LUMBAR PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Karla Schaffner |
| Correspondent | Karla Schaffner ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-04 |
| Decision Date | 2010-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856063044 | K101255 | 000 |
| 00844856037021 | K101255 | 000 |
| 00844856062894 | K101255 | 000 |
| 00844856062900 | K101255 | 000 |
| 00844856062917 | K101255 | 000 |
| 00844856062924 | K101255 | 000 |
| 00844856062931 | K101255 | 000 |
| 00844856062948 | K101255 | 000 |
| 00844856062955 | K101255 | 000 |
| 00844856062962 | K101255 | 000 |
| 00844856062979 | K101255 | 000 |
| 00844856062986 | K101255 | 000 |
| 00844856062993 | K101255 | 000 |
| 00844856063006 | K101255 | 000 |
| 00844856063013 | K101255 | 000 |
| 00844856063020 | K101255 | 000 |
| 00844856063037 | K101255 | 000 |
| 00844856036956 | K101255 | 000 |