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Instrument Makar Perfix Interference Bone Screw

by Instrument Makar, Inc.

510(k) K930980

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK930980 Date10 Feb 1994DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SN

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Instrument Makar Perfix Interference Bone Screw is a self-tapping orthopedic fixation device designed for internal bone stabilization. It features an interference fit mechanism to securely anchor bone fragments or implants, providing rigid fixation in orthopedic procedures such as fracture repair or joint arthroplasty.

This device is supplied sterile and intended for single-use, as indicated by its FDA 510(k) clearance under product code HWC (Orthopedic). It is classified under the Orthopedic advisory committee and was cleared for use in 1994. The screw is intended for use in controlled surgical settings and adheres to standard orthopedic sterilization and handling protocols.

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