Skip to content

Exactech Bone Screw

by Exactech, Inc.

510(k) K896601

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)SESE Substantially Equivalent · Traditional NumberK896601 Date6 Dec 1989ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

Overview

AI-generated summary, 20 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 Exactech Bone Screw is a Class II orthopedic fixation device designed for internal skeletal stabilization. It is intended for use in orthopedic procedures to secure bone fragments or components, providing mechanical support during the healing process. Constructed for durability and precision, it aligns with the HWC product code category for orthopedic screws.

This device is supplied sterile and intended for single-use, adhering to FDA 510(k) clearance (K896601) under the Traditional pathway. It is manufactured by Exactech, Inc., based in Gainesville, Florida, and is regulated as a Class II orthopedic implant. No additional MRI safety or size specifications are noted in the available data.

Other devices from Exactech, Inc.

See all devices from Exactech, Inc. →