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FDA 510(k)

IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED

K-Number: K971705 · 1997-08-06

ApplicantImplex Corp.
Decision Date1997-08-06
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED is the device name listed in this FDA 510(k) record. The listed applicant is Implex Corp.. It received FDA 510(k) clearance on 1997-08-06 under 510(k) number K971705. 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 IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED?

IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Implex Corp.. The 510(k) number is K971705.

When did IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED receive FDA 510(k) clearance?

IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED received FDA 510(k) clearance on 1997-08-06, under 510(k) number K971705.

Who is the listed applicant for IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED?

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

What is the FDA product code for IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED?

The FDA product code for IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED is JDI.

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Other records listing Implex 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.

K051978TRABECULAR METAL VERTEBRAL BODY REPLACEMENTK051196TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1K040487TRABECULAR METAL KNEE SYSTEM AUGMENTSK040630TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZK040756THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXXK031962NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS

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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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