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FDA 510(k)

ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED

K-Number: K901240 · 1990-03-26

ApplicantMed-Tek Corp.
Decision Date1990-03-26
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED 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 1990-03-26 under 510(k) number K901240. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED?

ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED is a medical device that received FDA 510(k) clearance on 1990-03-26. The listed applicant is Med-Tek Corp.. The 510(k) number is K901240.

When did ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED receive FDA 510(k) clearance?

ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED received FDA 510(k) clearance on 1990-03-26, under 510(k) number K901240.

Who is the listed applicant for ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED?

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 ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED?

The FDA product code for ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED 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 PROSTHESISK901451F-20 CEMENTED METAL-BACKED ACETABULAR CUPK900428ANESTHESIA BREATHING CIRCUITSK901626H.N. METAL BACKED ACETABULAR CUP, NONCEMENTEDK901594H.N. 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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