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FDA 510(k)

SYNERGY TISSUE MATRIX

K-Number: K113460 · 2012-01-11

ApplicantSynovis Orthopedic & Woundcare
Decision Date2012-01-11
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNERGY TISSUE MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Orthopedic & Woundcare. It received FDA 510(k) clearance on 2012-01-11 under 510(k) number K113460. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNERGY TISSUE MATRIX?

SYNERGY TISSUE MATRIX is a medical device that received FDA 510(k) clearance on 2012-01-11. The listed applicant is Synovis Orthopedic & Woundcare. The 510(k) number is K113460.

When did SYNERGY TISSUE MATRIX receive FDA 510(k) clearance?

SYNERGY TISSUE MATRIX received FDA 510(k) clearance on 2012-01-11, under 510(k) number K113460.

Who is the listed applicant for SYNERGY TISSUE MATRIX?

The FDA 510(k) record lists Synovis Orthopedic & Woundcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNERGY TISSUE MATRIX?

The FDA product code for SYNERGY TISSUE MATRIX is FTM.

Related Clinical Trials

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Other records listing Synovis Orthopedic & Woundcare as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112399UNITE BIOMATRIXK110538PRO FIXATION SYSTEM

Related Devices (Code: FTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston ScientificK250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K233991CanGaroo RM Antibacterial EnvelopeElutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.

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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