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FDA 510(k)

SYNOVIS COLLAGEN MATRIX (TBD)

K-Number: K122306 · 2013-03-08

ApplicantSynovis Surgical Innovations
Decision Date2013-03-08
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYNOVIS COLLAGEN MATRIX (TBD) is the device name listed in this FDA 510(k) record. The listed applicant is Synovis Surgical Innovations. It received FDA 510(k) clearance on 2013-03-08 under 510(k) number K122306. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNOVIS COLLAGEN MATRIX (TBD)?

SYNOVIS COLLAGEN MATRIX (TBD) is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Synovis Surgical Innovations. The 510(k) number is K122306.

When did SYNOVIS COLLAGEN MATRIX (TBD) receive FDA 510(k) clearance?

SYNOVIS COLLAGEN MATRIX (TBD) received FDA 510(k) clearance on 2013-03-08, under 510(k) number K122306.

Who is the listed applicant for SYNOVIS COLLAGEN MATRIX (TBD)?

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

What is the FDA product code for SYNOVIS COLLAGEN MATRIX (TBD)?

The FDA product code for SYNOVIS COLLAGEN MATRIX (TBD) is DXZ.

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Other records listing Synovis Surgical Innovations 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.

K083039VERITAS COLLAGEN MATRIX (DRY)K062915VERITAS COLLAGEN MATRIXK041669VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSDK040415PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENTK040119PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATIONK040001STEERABLE STYLET

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Related Devices (Code: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122105SMI CARDIOVASCULAR PATCHSolinas Medical, 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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