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FDA 510(k)

TECHMEDICA CAD/CAM CUSTOM HIP

K-Number: K911058 · 1993-02-23

ApplicantTechmedica, Inc.
Decision Date1993-02-23
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TECHMEDICA CAD/CAM CUSTOM HIP is the device name listed in this FDA 510(k) record. The listed applicant is Techmedica, Inc.. It received FDA 510(k) clearance on 1993-02-23 under 510(k) number K911058. 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 TECHMEDICA CAD/CAM CUSTOM HIP?

TECHMEDICA CAD/CAM CUSTOM HIP is a medical device that received FDA 510(k) clearance on 1993-02-23. The listed applicant is Techmedica, Inc.. The 510(k) number is K911058.

When did TECHMEDICA CAD/CAM CUSTOM HIP receive FDA 510(k) clearance?

TECHMEDICA CAD/CAM CUSTOM HIP received FDA 510(k) clearance on 1993-02-23, under 510(k) number K911058.

Who is the listed applicant for TECHMEDICA CAD/CAM CUSTOM HIP?

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

What is the FDA product code for TECHMEDICA CAD/CAM CUSTOM HIP?

The FDA product code for TECHMEDICA CAD/CAM CUSTOM HIP is JDI.

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Other records listing Techmedica, 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.

K933935CKS POROUS COATED FEMORAL COMPONENTK932017TECHMEDICA CONTINUUM HIP WITH HA COATINGK931929TECHMEDICA CONTINUUM HIP SYSTEMK926387TECHMEDICA STANDARD CEMENTED HIP SYSTEMK925420TECHMEDICA STANDARD BIPOLAR SYSTEMK923808MULLER STRAIGHT STEM FEMORAL 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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