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FDA 510(k)

SURFACE REPLACEMENT HIP PROSTHESIS

K-Number: K811718 · 1981-09-18

ApplicantBiomet, Inc.
Decision Date1981-09-18
Product CodeKYB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SURFACE REPLACEMENT HIP PROSTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1981-09-18 under 510(k) number K811718. The device is classified under product code KYB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFACE REPLACEMENT HIP PROSTHESIS?

SURFACE REPLACEMENT HIP PROSTHESIS is a medical device that received FDA 510(k) clearance on 1981-09-18. The listed applicant is Biomet, Inc.. The 510(k) number is K811718.

When did SURFACE REPLACEMENT HIP PROSTHESIS receive FDA 510(k) clearance?

SURFACE REPLACEMENT HIP PROSTHESIS received FDA 510(k) clearance on 1981-09-18, under 510(k) number K811718.

Who is the listed applicant for SURFACE REPLACEMENT HIP PROSTHESIS?

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 SURFACE REPLACEMENT HIP PROSTHESIS?

The FDA product code for SURFACE REPLACEMENT HIP PROSTHESIS is KYB.

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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: KYB)

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.

K081382DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786Duckworth & Kent, Ltd.K072985DUCKWORTH & KENT LTD INJECTOR, MODEL: DK7797-2Duckworth & Kent, Ltd.K070669IOL INJECTOR SETMedicel AGK063155MONARCH III IOL DELIVERY SYSTEMAlcon Manufacturing, Ltd.K063694AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28Bausch & Lomb, Inc.K032412RE-USEABLE MICROSTAAR INJECTOR, MSI-SStaar Surgical Co.

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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