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FDA 510(k)

OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES

K-Number: K913812 · 1991-11-22

ApplicantOsteonics Corp.
Decision Date1991-11-22
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K913812. 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 OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES?

OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Osteonics Corp.. The 510(k) number is K913812.

When did OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES receive FDA 510(k) clearance?

OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES received FDA 510(k) clearance on 1991-11-22, under 510(k) number K913812.

Who is the listed applicant for OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES?

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

What is the FDA product code for OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES?

The FDA product code for OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES is JDI.

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Other records listing Osteonics 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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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