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FDA 510(k)

OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM

K-Number: K111326 · 2011-07-06

ApplicantGraham Medical Technologies, LLC
Decision Date2011-07-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Graham Medical Technologies, LLC. It received FDA 510(k) clearance on 2011-07-06 under 510(k) number K111326. 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 OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM?

OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-06. The listed applicant is Graham Medical Technologies, LLC. The 510(k) number is K111326.

When did OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM receive FDA 510(k) clearance?

OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM received FDA 510(k) clearance on 2011-07-06, under 510(k) number K111326.

Who is the listed applicant for OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM?

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

What is the FDA product code for OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM?

The FDA product code for OSTEOWEDGE OPENING WEDGE BONE LOCKING SYSTEM 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 Graham Medical Technologies, 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.

K042030HYPROCURE SUBTALAR IMPLANT 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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