FDA 510(k)

K'FIX

K-Number: K010847 · 2001-06-19

Decision Date2001-06-19

Product CodeNDL

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

K'FIX is the device name listed in this FDA 510(k) record. The listed applicant is Avanta Orthopaedics, Inc.. It received FDA 510(k) clearance on 2001-06-19 under 510(k) number K010847. The device is classified under product code NDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K'FIX?

K'FIX is a medical device that received FDA 510(k) clearance on 2001-06-19. The listed applicant is Avanta Orthopaedics, Inc.. The 510(k) number is K010847.

When did K'FIX receive FDA 510(k) clearance?

K'FIX received FDA 510(k) clearance on 2001-06-19, under 510(k) number K010847.

Who is the listed applicant for K'FIX?

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

What is the FDA product code for K'FIX?

The FDA product code for K'FIX is NDL.

Other records listing Avanta Orthopaedics, 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.

K030881AVANTA CARPAL FUSION PLATING SYSTEM K021859WRIST IMPLANT K023604MODIFICATION TO RADIAL HEAD IMPLANT K013629FINGER JOINT PROSTHESIS K011819RADIAL HEAD IMPLANT K003033SCAPHIX, STAPLE, FIXATION, BONE

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Related Devices (Code: NDL)

K010545TBWTri-Med, 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.