The following data is part of a premarket notification filed by Medicrea International with the FDA for Infinity™ Oct System And Pass Oct Spinal System.
Device ID | K220810 |
510k Number | K220810 |
Device Name: | Infinity™ OCT System And PASS OCT Spinal System |
Classification | Posterior Cervical Screw System |
Applicant | Medicrea International 5389 Route De Strasbourg - Vancia Rillieux-La-Pape, FR 69140 |
Contact | Karine Trogneux |
Correspondent | Karine Trogneux Medicrea International 5389 Route De Strasbourg - Vancia Rillieux-La-Pape, FR 69140 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-21 |
Decision Date | 2022-04-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03613720287674 | K220810 | 000 |
03613720289852 | K220810 | 000 |
03613720289876 | K220810 | 000 |
03613720289890 | K220810 | 000 |
03613720289913 | K220810 | 000 |
03613720289937 | K220810 | 000 |
03613720289951 | K220810 | 000 |
03613720289975 | K220810 | 000 |
03613720289999 | K220810 | 000 |
03613720290018 | K220810 | 000 |
03613720287650 | K220810 | 000 |
03613720289838 | K220810 | 000 |
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