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FDA 510(k)

COLLAGEN BONE HEALING PROTECTIVE SHEET

K-Number: K052041 · 2005-10-25

ApplicantCollagen Matrix, Inc.
Decision Date2005-10-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COLLAGEN BONE HEALING PROTECTIVE SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Collagen Matrix, Inc.. It received FDA 510(k) clearance on 2005-10-25 under 510(k) number K052041. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLAGEN BONE HEALING PROTECTIVE SHEET?

COLLAGEN BONE HEALING PROTECTIVE SHEET is a medical device that received FDA 510(k) clearance on 2005-10-25. The listed applicant is Collagen Matrix, Inc.. The 510(k) number is K052041.

When did COLLAGEN BONE HEALING PROTECTIVE SHEET receive FDA 510(k) clearance?

COLLAGEN BONE HEALING PROTECTIVE SHEET received FDA 510(k) clearance on 2005-10-25, under 510(k) number K052041.

Who is the listed applicant for COLLAGEN BONE HEALING PROTECTIVE SHEET?

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

What is the FDA product code for COLLAGEN BONE HEALING PROTECTIVE SHEET?

The FDA product code for COLLAGEN BONE HEALING PROTECTIVE SHEET is HRS.

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Other records listing Collagen Matrix, Inc. as applicant

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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