IdentiTi II Interbody System
K-Number: K242364 · 2024-10-04
ApplicantAlphatec Spine, Inc.
Decision Date2024-10-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
IdentiTi II Interbody System is a medical device manufactured by Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-10-04 under approval number K242364. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the IdentiTi II Interbody System?
IdentiTi II Interbody System is a medical device that received FDA 510(k) clearance on 2024-10-04. It is manufactured by Alphatec Spine, Inc.. The 510(k) number is K242364.
When was IdentiTi II Interbody System approved by the FDA?
IdentiTi II Interbody System received FDA 510(k) clearance on 2024-10-04, under approval number K242364.
What company makes IdentiTi II Interbody System?
IdentiTi II Interbody System is manufactured by Alphatec Spine, Inc..
What is the FDA product code for IdentiTi II Interbody System?
The FDA product code for IdentiTi II Interbody System is MAX.
Related Clinical Trials
Other Devices by Alphatec Spine, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.