ORIA ZENITH
Appliance, Fixation, Spinal Intervertebral Body
ORTHOTEC, L.L.C.
The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Oria Zenith.
Pre-market Notification Details
| Device ID | K030500 |
| 510k Number | K030500 |
| Device Name: | ORIA ZENITH |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills, CA 90212 |
| Contact | Patrick Bertranou |
| Correspondent | Patrick Bertranou ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills, CA 90212 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-03-20 |
| Summary: | summary |
Trademark Results [ORIA ZENITH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORIA ZENITH 78244542 not registered Dead/Abandoned |
EUROSURGICAL, S.A. 2003-05-01 |
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