The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synapse System.
Device ID | K070573 |
510k Number | K070573 |
Device Name: | SYNAPSE SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Contact | Susan Lewandowski |
Correspondent | Susan Lewandowski SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-28 |
Decision Date | 2007-06-08 |
Summary: | summary |