The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Oc Fusion System.
Device ID | K053418 |
510k Number | K053418 |
Device Name: | SYNTHES OC FUSION SYSTEM |
Classification | Appliance, Fixation, Spinal Interlaminal |
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 | KWP |
CFR Regulation Number | 888.3050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-12-08 |
Decision Date | 2006-09-06 |
Summary: | summary |