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FDA 510(k)

COBRA EXTERNAL FIXATOR

K-Number: K983881 · 1998-12-04

ApplicantOrthopaedic Innovations, Inc.
Decision Date1998-12-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COBRA EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Innovations, Inc.. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K983881. 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 COBRA EXTERNAL FIXATOR?

COBRA EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Orthopaedic Innovations, Inc.. The 510(k) number is K983881.

When did COBRA EXTERNAL FIXATOR receive FDA 510(k) clearance?

COBRA EXTERNAL FIXATOR received FDA 510(k) clearance on 1998-12-04, under 510(k) number K983881.

Who is the listed applicant for COBRA EXTERNAL FIXATOR?

The FDA 510(k) record lists Orthopaedic Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBRA EXTERNAL FIXATOR?

The FDA product code for COBRA EXTERNAL FIXATOR is HRS.

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Other records listing Orthopaedic Innovations, Inc. 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.

K020145ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEMK962646PRIME MODULAR ENDO HEADK960014PRACTIFIX EXTERNAL FIXATION SYSTEMK955620PRIME CEMENTED CALCAR FEMORAL STEMSK955751PRIME FEMORAL CEMENT PLUGK953033PRIME CEMENTED SMALL FEMORAL STEM

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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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