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FDA 510(k)

PRECISION STRATA TOTAL HIP STEM

K-Number: K921383 · 1992-06-25

ApplicantHowmedica Corp.
Decision Date1992-06-25
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECISION STRATA TOTAL HIP STEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1992-06-25 under 510(k) number K921383. 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 PRECISION STRATA TOTAL HIP STEM?

PRECISION STRATA TOTAL HIP STEM is a medical device that received FDA 510(k) clearance on 1992-06-25. The listed applicant is Howmedica Corp.. The 510(k) number is K921383.

When did PRECISION STRATA TOTAL HIP STEM receive FDA 510(k) clearance?

PRECISION STRATA TOTAL HIP STEM received FDA 510(k) clearance on 1992-06-25, under 510(k) number K921383.

Who is the listed applicant for PRECISION STRATA TOTAL HIP STEM?

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

What is the FDA product code for PRECISION STRATA TOTAL HIP STEM?

The FDA product code for PRECISION STRATA TOTAL HIP STEM is JDI.

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Related Devices (Code: JDI)

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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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