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FDA 510(k)

ORTHOPEDIC SALVAGE SYSTEM- OSS

K-Number: K052685 · 2005-10-27

ApplicantBiomet, Inc.
Decision Date2005-10-27
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC SALVAGE SYSTEM- OSS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2005-10-27 under 510(k) number K052685. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPEDIC SALVAGE SYSTEM- OSS?

ORTHOPEDIC SALVAGE SYSTEM- OSS is a medical device that received FDA 510(k) clearance on 2005-10-27. The listed applicant is Biomet, Inc.. The 510(k) number is K052685.

When did ORTHOPEDIC SALVAGE SYSTEM- OSS receive FDA 510(k) clearance?

ORTHOPEDIC SALVAGE SYSTEM- OSS received FDA 510(k) clearance on 2005-10-27, under 510(k) number K052685.

Who is the listed applicant for ORTHOPEDIC SALVAGE SYSTEM- OSS?

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 ORTHOPEDIC SALVAGE SYSTEM- OSS?

The FDA product code for ORTHOPEDIC SALVAGE SYSTEM- OSS is KRO.

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Other records listing Biomet, Inc. as applicant

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Related Devices (Code: KRO)

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.

K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker OrthopaedicsK252898Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge BumperHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK252303Stem Extension Line (USTAR II System)United Orthopedic CorporationK251665Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK242871ATTUNE™ Revision Hinge KneeDepuy Ireland UCK240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial InseMicroport Orthopedics, Inc.

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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