The following data is part of a premarket notification filed by Medicrea International S.a with the FDA for Pass Oct Spinal System.
Device ID | K161149 |
510k Number | K161149 |
Device Name: | PASS OCT Spinal System |
Classification | Posterior Cervical Screw System |
Applicant | MEDICREA INTERNATIONAL S.A 14 PORTE DU GRAND LYON Neyron, FR 01700 |
Contact | David Ryan |
Correspondent | David Ryan MEDICREA INTERNATIONAL S.A 14 PORTE DU GRAND LYON Neyron, FR 01700 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-25 |
Decision Date | 2016-07-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03613720266808 | K161149 | 000 |
03613720266792 | K161149 | 000 |
03613720266785 | K161149 | 000 |
03613720266778 | K161149 | 000 |
03613720265016 | K161149 | 000 |
03613720265009 | K161149 | 000 |
03613720237068 | K161149 | 000 |