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FDA 510(k)

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW

K-Number: K130731 · 2013-07-19

ApplicantStabiliz Orthopaedics, LLC
Decision Date2013-07-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Stabiliz Orthopaedics, LLC. It received FDA 510(k) clearance on 2013-07-19 under 510(k) number K130731. 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 STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW?

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW is a medical device that received FDA 510(k) clearance on 2013-07-19. The listed applicant is Stabiliz Orthopaedics, LLC. The 510(k) number is K130731.

When did STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW receive FDA 510(k) clearance?

STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW received FDA 510(k) clearance on 2013-07-19, under 510(k) number K130731.

Who is the listed applicant for STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW?

The FDA 510(k) record lists Stabiliz Orthopaedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW?

The FDA product code for STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW is HRS.

Related Clinical Trials

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.

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Other records listing Stabiliz Orthopaedics, LLC 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.

K120651STABILIZ FIXATION SYSTEM

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

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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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