The following data is part of a premarket notification filed by Medtronic with the FDA for Infinity™ Oct System, Pass Oct® Spinal System.
Device ID | K210449 |
510k Number | K210449 |
Device Name: | Infinity™ OCT System, PASS OCT® Spinal System |
Classification | Posterior Cervical Screw System |
Applicant | Medtronic 1800 Pyramid Place Memphis, TN 38132 |
Contact | Shweta Sharma |
Correspondent | Shweta Sharma Medtronic 1800 Pyramid Place Memphis, TN 38132 |
Product Code | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-02-16 |
Decision Date | 2021-03-18 |
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