T2— 510(k) K212303

Substantially Equivalent

Osstem Implant Co., Ltd.

FDA 510(k) clearance K212303 for T2, Substantially Equivalent on 2021-09-21. Applicant: Osstem Implant Co., Ltd..

Clearance details

Applicant: Osstem Implant Co., Ltd.
Product code: Code OAS
Advisory panel: Radiology
Date received: 2021-07-23
Decision date: 2021-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-Si, KR

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