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FDA 510(k)

CP-FIBER (ORTHOFIBER)

K-Number: K094028 · 2010-03-18

ApplicantCp Medical
Decision Date2010-03-18
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CP-FIBER (ORTHOFIBER) is the device name listed in this FDA 510(k) record. The listed applicant is Cp Medical. It received FDA 510(k) clearance on 2010-03-18 under 510(k) number K094028. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CP-FIBER (ORTHOFIBER)?

CP-FIBER (ORTHOFIBER) is a medical device that received FDA 510(k) clearance on 2010-03-18. The listed applicant is Cp Medical. The 510(k) number is K094028.

When did CP-FIBER (ORTHOFIBER) receive FDA 510(k) clearance?

CP-FIBER (ORTHOFIBER) received FDA 510(k) clearance on 2010-03-18, under 510(k) number K094028.

Who is the listed applicant for CP-FIBER (ORTHOFIBER)?

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

What is the FDA product code for CP-FIBER (ORTHOFIBER)?

The FDA product code for CP-FIBER (ORTHOFIBER) is GAT.

Related Clinical Trials

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Other records listing Cp Medical 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.

K072229MONOSWIFTK071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERSK060987OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31K041894ORTHOFIBERK034062CP SLEEVE AND RIVER SLEEVEK024372CP MEDICAL BONE WAX

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Related Devices (Code: GAT)

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K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, 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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