ARCOFIX
Appliance, Fixation, Spinal Intervertebral Body
SYNTHES SPINE CO.LP
The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Arcofix.
Pre-market Notification Details
| Device ID | K080020 |
| 510k Number | K080020 |
| Device Name: | ARCOFIX |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Kirsten Stowell |
| Correspondent | Kirsten Stowell SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-03 |
| Decision Date | 2008-05-23 |
| Summary: | summary |
Trademark Results [ARCOFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ARCOFIX 72124464 0734849 Dead/Cancelled |
Societe Anonyme des Ateliers de Secheron 1961-07-21 |
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