The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Admiral Acp System.
Device ID | K212139 |
510k Number | K212139 |
Device Name: | Admiral ACP System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
Contact | Cindy Fong |
Correspondent | Cindy Fong SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-07-08 |
Decision Date | 2021-09-01 |