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FDA 510(k)

COLLAGEN TENDON SHEET-D

K-Number: K122048 · 2013-01-08

ApplicantRotation Medical, Inc.
Decision Date2013-01-08
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COLLAGEN TENDON SHEET-D 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 2013-01-08 under 510(k) number K122048. 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-D?

COLLAGEN TENDON SHEET-D is a medical device that received FDA 510(k) clearance on 2013-01-08. The listed applicant is Rotation Medical, Inc.. The 510(k) number is K122048.

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

COLLAGEN TENDON SHEET-D received FDA 510(k) clearance on 2013-01-08, under 510(k) number K122048.

Who is the listed applicant for COLLAGEN TENDON SHEET-D?

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-D?

The FDA product code for COLLAGEN TENDON SHEET-D 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)K112423COLLAGEN TENDON SHEET

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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