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FDA 510(k)

MTF FASCIA

K-Number: K120479 · 2012-11-08

ApplicantMusculoskeletal Transplant Foundation
Decision Date2012-11-08
Product CodeOWY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MTF FASCIA is the device name listed in this FDA 510(k) record. The listed applicant is Musculoskeletal Transplant Foundation. It received FDA 510(k) clearance on 2012-11-08 under 510(k) number K120479. The device is classified under product code OWY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MTF FASCIA?

MTF FASCIA is a medical device that received FDA 510(k) clearance on 2012-11-08. The listed applicant is Musculoskeletal Transplant Foundation. The 510(k) number is K120479.

When did MTF FASCIA receive FDA 510(k) clearance?

MTF FASCIA received FDA 510(k) clearance on 2012-11-08, under 510(k) number K120479.

Who is the listed applicant for MTF FASCIA?

The FDA 510(k) record lists Musculoskeletal Transplant Foundation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTF FASCIA?

The FDA product code for MTF FASCIA is OWY.

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Other records listing Musculoskeletal Transplant Foundation 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.

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Related Devices (Code: OWY)

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.

K251690Arthrex SpeedFLEX™ ImplantArthrex, Inc.K252647Tapestry Biointegrative ImplantEmbody, Inc.K250109TYBR Collagen GelTybr HealthK243843Tendon Protect (50242)Kerecis LimitedK242631REGENETEN™ Bioinductive ImplantSmith & Nephew Inc., Endoscopy Div.K222501Regeneten Bioinductive ImplantSmith and Nephew, Inc.

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.

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