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FDA 510(k)

SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS

K-Number: K051879 · 2005-10-05

ApplicantSynthes (Usa)
Decision Date2005-10-05
Product CodeFTM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2005-10-05 under 510(k) number K051879. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS?

SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS is a medical device that received FDA 510(k) clearance on 2005-10-05. The listed applicant is Synthes (Usa). The 510(k) number is K051879.

When did SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS receive FDA 510(k) clearance?

SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS received FDA 510(k) clearance on 2005-10-05, under 510(k) number K051879.

Who is the listed applicant for SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS?

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

What is the FDA product code for SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS?

The FDA product code for SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS is FTM.

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Other records listing Synthes (Usa) 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.

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Related Devices (Code: FTM)

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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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