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FDA 510(k)

MAXLOCK EXTREME SYSTEM

K-Number: K122005 · 2012-09-06

ApplicantOrthohelix Surgical Designs, Inc.
Decision Date2012-09-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MAXLOCK EXTREME SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthohelix Surgical Designs, Inc.. It received FDA 510(k) clearance on 2012-09-06 under 510(k) number K122005. 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 MAXLOCK EXTREME SYSTEM?

MAXLOCK EXTREME SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is Orthohelix Surgical Designs, Inc.. The 510(k) number is K122005.

When did MAXLOCK EXTREME SYSTEM receive FDA 510(k) clearance?

MAXLOCK EXTREME SYSTEM received FDA 510(k) clearance on 2012-09-06, under 510(k) number K122005.

Who is the listed applicant for MAXLOCK EXTREME SYSTEM?

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

What is the FDA product code for MAXLOCK EXTREME SYSTEM?

The FDA product code for MAXLOCK EXTREME SYSTEM is HRS.

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Other records listing Orthohelix Surgical Designs, 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.

K132591MAXLOCK EXTREME SYSTEMK130832ORTHOHELIX STAPLE SYSTEMK131324MAXTORQUE SCREW SYSTEMK123203MAXLOCK EXTREME SYSTEM MODEL MXLK121437MINI MAXLOCK EXTREME PLATING SYSTEMK120165INTRAOSSEOUS FIXATION SYSTEM

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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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