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FDA 510(k)

COLLAGEN TENDON SHEET

K-Number: K112423 · 2011-12-22

ApplicantRotation Medical, Inc.
Decision Date2011-12-22
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COLLAGEN TENDON SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Rotation Medical, Inc.. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K112423. 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 COLLAGEN TENDON SHEET?

COLLAGEN TENDON SHEET is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Rotation Medical, Inc.. The 510(k) number is K112423.

When did COLLAGEN TENDON SHEET receive FDA 510(k) clearance?

COLLAGEN TENDON SHEET received FDA 510(k) clearance on 2011-12-22, under 510(k) number K112423.

Who is the listed applicant for COLLAGEN TENDON SHEET?

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

What is the FDA product code for COLLAGEN TENDON SHEET?

The FDA product code for COLLAGEN TENDON SHEET is FTM.

Related Clinical Trials

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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Other records listing Rotation Medical, Inc. 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.

K131635ROTATION MEDICAL BONE STAPLE (RMB STAPLE)K131637ROTATION MEDICAL SOFT TISSUE STAPLE (RMST STAPLE)K122048COLLAGEN TENDON SHEET-D

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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