The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Navigable Pedicle Preparation Instruments.
| Device ID | K122211 |
| 510k Number | K122211 |
| Device Name: | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
| Contact | Hemal Mehta |
| Correspondent | Hemal Mehta SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester, PA 19380 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-25 |
| Decision Date | 2012-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611819588837 | K122211 | 000 |
| 07611819588684 | K122211 | 000 |
| 07611819588677 | K122211 | 000 |
| 07611819588653 | K122211 | 000 |
| 07611819588646 | K122211 | 000 |
| 07611819588639 | K122211 | 000 |
| 07611819588622 | K122211 | 000 |
| 07611819588615 | K122211 | 000 |
| 07611819588608 | K122211 | 000 |
| H981036324310 | K122211 | 000 |
| H981036324300 | K122211 | 000 |
| 07611819588721 | K122211 | 000 |
| 07611819588752 | K122211 | 000 |
| 07611819588790 | K122211 | 000 |
| H981036323130 | K122211 | 000 |
| 07611819588806 | K122211 | 000 |
| 07611819588967 | K122211 | 000 |
| 07611819588943 | K122211 | 000 |
| 07611819588936 | K122211 | 000 |
| 07611819588912 | K122211 | 000 |
| 07611819588882 | K122211 | 000 |
| 07611819588875 | K122211 | 000 |
| 07611819588868 | K122211 | 000 |
| H981036323350 | K122211 | 000 |
| H981036323070 | K122211 | 000 |