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FDA 510(k)

ANTERIOR STABILIZED TIBIAL BEARINGS

K-Number: K022586 · 2002-08-15

ApplicantBiomet Orthopedics, Inc.
Decision Date2002-08-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTERIOR STABILIZED TIBIAL BEARINGS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2002-08-15 under 510(k) number K022586. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTERIOR STABILIZED TIBIAL BEARINGS?

ANTERIOR STABILIZED TIBIAL BEARINGS is a medical device that received FDA 510(k) clearance on 2002-08-15. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K022586.

When did ANTERIOR STABILIZED TIBIAL BEARINGS receive FDA 510(k) clearance?

ANTERIOR STABILIZED TIBIAL BEARINGS received FDA 510(k) clearance on 2002-08-15, under 510(k) number K022586.

Who is the listed applicant for ANTERIOR STABILIZED TIBIAL BEARINGS?

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

What is the FDA product code for ANTERIOR STABILIZED TIBIAL BEARINGS?

The FDA product code for ANTERIOR STABILIZED TIBIAL BEARINGS is JWH.

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Other records listing Biomet Orthopedics, 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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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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