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FDA 510(k)

ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT

K-Number: K921182 · 1993-07-23

ApplicantBiomet, Inc.
Decision Date1993-07-23
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1993-07-23 under 510(k) number K921182. 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 ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT?

ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT is a medical device that received FDA 510(k) clearance on 1993-07-23. The listed applicant is Biomet, Inc.. The 510(k) number is K921182.

When did ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT receive FDA 510(k) clearance?

ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT received FDA 510(k) clearance on 1993-07-23, under 510(k) number K921182.

Who is the listed applicant for ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT?

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

What is the FDA product code for ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT?

The FDA product code for ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT is JWH.

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Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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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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