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FDA 510(k)

OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS

K-Number: K983152 · 1998-09-25

ApplicantOsteonics Corp.
Decision Date1998-09-25
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1998-09-25 under 510(k) number K983152. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS?

OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS is a medical device that received FDA 510(k) clearance on 1998-09-25. The listed applicant is Osteonics Corp.. The 510(k) number is K983152.

When did OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS receive FDA 510(k) clearance?

OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS received FDA 510(k) clearance on 1998-09-25, under 510(k) number K983152.

Who is the listed applicant for OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS?

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 OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS?

The FDA product code for OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS is MNH. This falls under the ENT category.

Related Clinical Trials

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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: MNH)

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.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

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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