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FDA 510(k)

LINK CERAMIC HEADS 14/16 X 32MM

K-Number: K931572 · 1994-03-28

ApplicantLink America, Inc.
Decision Date1994-03-28
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK CERAMIC HEADS 14/16 X 32MM is the device name listed in this FDA 510(k) record. The listed applicant is Link America, Inc.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K931572. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK CERAMIC HEADS 14/16 X 32MM?

LINK CERAMIC HEADS 14/16 X 32MM is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Link America, Inc.. The 510(k) number is K931572.

When did LINK CERAMIC HEADS 14/16 X 32MM receive FDA 510(k) clearance?

LINK CERAMIC HEADS 14/16 X 32MM received FDA 510(k) clearance on 1994-03-28, under 510(k) number K931572.

Who is the listed applicant for LINK CERAMIC HEADS 14/16 X 32MM?

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

What is the FDA product code for LINK CERAMIC HEADS 14/16 X 32MM?

The FDA product code for LINK CERAMIC HEADS 14/16 X 32MM is LZO.

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Other records listing Link America, 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.

K972760LINK, ACETABULAR REVISION MESH CUPK964458ELLIS EXTERNAL MINI-FIXATOR SYSTEMK955296LINK MP RECONSTRUCTION HIPK954186SLED UNICOMPARTMENT KNEE SYSTEMK931571LINK CERAMIC HEADS 12/14 X 32MMK920756FELDMUHLE CERAMIC HEAD

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast 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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