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FDA 510(k)

PENNSYLVANIA HOSPITAL HIP SYS

K-Number: K841437 · 1984-06-25

ApplicantBiomet, Inc.
Decision Date1984-06-25
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PENNSYLVANIA HOSPITAL HIP SYS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1984-06-25 under 510(k) number K841437. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENNSYLVANIA HOSPITAL HIP SYS?

PENNSYLVANIA HOSPITAL HIP SYS is a medical device that received FDA 510(k) clearance on 1984-06-25. The listed applicant is Biomet, Inc.. The 510(k) number is K841437.

When did PENNSYLVANIA HOSPITAL HIP SYS receive FDA 510(k) clearance?

PENNSYLVANIA HOSPITAL HIP SYS received FDA 510(k) clearance on 1984-06-25, under 510(k) number K841437.

Who is the listed applicant for PENNSYLVANIA HOSPITAL HIP SYS?

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 PENNSYLVANIA HOSPITAL HIP SYS?

The FDA product code for PENNSYLVANIA HOSPITAL HIP SYS is KWL.

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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: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbH

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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