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Reprocessed Stryker Arthroscopic Shavers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012635

by Alliance Medical, Inc.

Identifiers

510(k) Number
K012635 FDA 510(k)
FDA Product Code
HRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.1100 FDA 510(k)
Regulation Number
888.1100 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Reprocessed Stryker Arthroscopic Shavers are arthroscopic shaver components that include a bur or blade at the end of a long rod rotating within a long hollow stainless steel housing. They are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot, and plastic surgery in patients requiring arthroscopic or orthopedic surgery.

These devices are reprocessed by Alliance Medical, Inc. and were granted FDA 510(k) clearance under K012635 on November 7, 2001, as substantially equivalent to a predicate device. They are supplied as reprocessed single-use devices for use in orthopedic and related surgical settings, with no claims made regarding sterility, MRI safety, sizes, or storage conditions in the provided data.

Frequently asked questions

What are Reprocessed Stryker Arthroscopic Shavers used for?

They are intended for resecting tissue and bone found in articular body cavities during orthopedic, maxillofacial, hand, foot, and plastic surgery in patients requiring arthroscopic or orthopedic surgery, as stated in the device description.

How are Reprocessed Stryker Arthroscopic Shavers supplied and intended for use?

They are supplied as reprocessed single-use devices for use in orthopedic and related surgical settings, meaning they are designed for one patient procedure after reprocessing by Alliance Medical, Inc.

What regulatory clearance do Reprocessed Stryker Arthroscopic Shavers have?

They were granted FDA 510(k) clearance under K012635 on November 7, 2001, as substantially equivalent to a predicate device, based on the authorization and decision data provided.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Reprocessed Arthroscopic Shaver - Stryker, REPROCESSED STRYKER ARTHROSCOPIC SHAVERS (K012635) — FDA 510(k ..., Alliance Reprocessed Stryker Arthroscopic Shavers - allmed.wiki, REPROCESSED STRYKER ARTHROSCOPIC SHAVERS 510(k) K012635 - fda.report, Shavers - Stryker

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alliance Medical, Inc.
FDA Applicant
Alliance Medical Corp.

Sources (1)

  • FDA 510(k) K012635 24 fields · synced Oct 6, 2026