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FDA 510(k)

OSTEO COMPRESSION CONDYLE SCREW SYSTEM

K-Number: K983508 · 1998-12-07

ApplicantOsteonics Corp.
Decision Date1998-12-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO COMPRESSION CONDYLE SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1998-12-07 under 510(k) number K983508. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEO COMPRESSION CONDYLE SCREW SYSTEM?

OSTEO COMPRESSION CONDYLE SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-07. The listed applicant is Osteonics Corp.. The 510(k) number is K983508.

When did OSTEO COMPRESSION CONDYLE SCREW SYSTEM receive FDA 510(k) clearance?

OSTEO COMPRESSION CONDYLE SCREW SYSTEM received FDA 510(k) clearance on 1998-12-07, under 510(k) number K983508.

Who is the listed applicant for OSTEO COMPRESSION CONDYLE SCREW SYSTEM?

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 OSTEO COMPRESSION CONDYLE SCREW SYSTEM?

The FDA product code for OSTEO COMPRESSION CONDYLE SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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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: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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