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FDA 510(k)

S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD

K-Number: K921111 · 1992-10-22

ApplicantJoint Medical Products Corp.
Decision Date1992-10-22
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Joint Medical Products Corp.. It received FDA 510(k) clearance on 1992-10-22 under 510(k) number K921111. 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 S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD?

S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1992-10-22. The listed applicant is Joint Medical Products Corp.. The 510(k) number is K921111.

When did S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD receive FDA 510(k) clearance?

S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD received FDA 510(k) clearance on 1992-10-22, under 510(k) number K921111.

Who is the listed applicant for S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD?

The FDA 510(k) record lists Joint Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD?

The FDA product code for S-ROM ZIRCONIA CERMAMIC FEMORAL HEAD is LZO.

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Other records listing Joint Medical Products Corp. 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.

K955511ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUPK954935S-ROM FEMORAL HIP STEM - SIZE 14 X 8K944321S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM IIK951726S-ROM ZTP UHMWPE ACETABULAR CUPK951084S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESISK951000ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM

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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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