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FDA 510(k)

STR GRAFT

K-Number: K121216 · 2012-11-21

ApplicantSoft Tissue Regeneration, Inc.
Decision Date2012-11-21
Product CodeOWW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Soft Tissue Regeneration, Inc.. It received FDA 510(k) clearance on 2012-11-21 under 510(k) number K121216. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STR GRAFT?

STR GRAFT is a medical device that received FDA 510(k) clearance on 2012-11-21. The listed applicant is Soft Tissue Regeneration, Inc.. The 510(k) number is K121216.

When did STR GRAFT receive FDA 510(k) clearance?

STR GRAFT received FDA 510(k) clearance on 2012-11-21, under 510(k) number K121216.

Who is the listed applicant for STR GRAFT?

The FDA 510(k) record lists Soft Tissue Regeneration, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STR GRAFT?

The FDA product code for STR GRAFT is OWW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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