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FDA 510(k)

ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS

K-Number: K971414 · 1997-07-16

ApplicantSmith & Nephew, Inc., Orthopaedic Div.
Decision Date1997-07-16
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. It received FDA 510(k) clearance on 1997-07-16 under 510(k) number K971414. 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 ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS?

ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 1997-07-16. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. The 510(k) number is K971414.

When did ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS receive FDA 510(k) clearance?

ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS received FDA 510(k) clearance on 1997-07-16, under 510(k) number K971414.

Who is the listed applicant for ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS?

The FDA 510(k) record lists Smith & Nephew, Inc., Orthopaedic Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS?

The FDA product code for ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS is LZO.

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Other records listing Smith & Nephew, Inc., Orthopaedic Div. 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: 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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