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FDA 510(k)

OSTEO ANATOMICAL BONE PLATES

K-Number: K972196 · 1997-08-25

ApplicantOsteonics Corp.
Decision Date1997-08-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO ANATOMICAL BONE PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1997-08-25 under 510(k) number K972196. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEO ANATOMICAL BONE PLATES?

OSTEO ANATOMICAL BONE PLATES is a medical device that received FDA 510(k) clearance on 1997-08-25. The listed applicant is Osteonics Corp.. The 510(k) number is K972196.

When did OSTEO ANATOMICAL BONE PLATES receive FDA 510(k) clearance?

OSTEO ANATOMICAL BONE PLATES received FDA 510(k) clearance on 1997-08-25, under 510(k) number K972196.

Who is the listed applicant for OSTEO ANATOMICAL BONE PLATES?

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 ANATOMICAL BONE PLATES?

The FDA product code for OSTEO ANATOMICAL BONE PLATES is HRS.

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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: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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