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FDA 510(k)

F-20 CEMENTED METAL-BACKED ACETABULAR CUP

K-Number: K901451 · 1990-08-31

ApplicantMed-Tek Corp.
Decision Date1990-08-31
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

F-20 CEMENTED METAL-BACKED ACETABULAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Med-Tek Corp.. It received FDA 510(k) clearance on 1990-08-31 under 510(k) number K901451. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the F-20 CEMENTED METAL-BACKED ACETABULAR CUP?

F-20 CEMENTED METAL-BACKED ACETABULAR CUP is a medical device that received FDA 510(k) clearance on 1990-08-31. The listed applicant is Med-Tek Corp.. The 510(k) number is K901451.

When did F-20 CEMENTED METAL-BACKED ACETABULAR CUP receive FDA 510(k) clearance?

F-20 CEMENTED METAL-BACKED ACETABULAR CUP received FDA 510(k) clearance on 1990-08-31, under 510(k) number K901451.

Who is the listed applicant for F-20 CEMENTED METAL-BACKED ACETABULAR CUP?

The FDA 510(k) record lists Med-Tek Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F-20 CEMENTED METAL-BACKED ACETABULAR CUP?

The FDA product code for F-20 CEMENTED METAL-BACKED ACETABULAR CUP is JDI.

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Other records listing Med-Tek 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.

K903234F-19 TOTAL HIP PROSTHESISK901687F-24 FEMORAL HIP PROSTHESISK900428ANESTHESIA BREATHING CIRCUITSK901626H.N. METAL BACKED ACETABULAR CUP, NONCEMENTEDK901594H.N. TOTAL HIP PROSTHESISK901480F-20 TOTAL HIP PROSTHESIS

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Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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