Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

osteo-WEDGE II ® Open Wedge Bone Locking Plate System

K-Number: K162179 · 2017-01-10

ApplicantGraham Medical Technologies, LLC Dba Gramedica
Decision Date2017-01-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

osteo-WEDGE II ® Open Wedge Bone Locking Plate System is a medical device manufactured by Graham Medical Technologies, LLC Dba Gramedica. It received FDA 510(k) clearance on 2017-01-10 under approval number K162179. 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-WEDGE II ® Open Wedge Bone Locking Plate System?

osteo-WEDGE II ® Open Wedge Bone Locking Plate System is a medical device that received FDA 510(k) clearance on 2017-01-10. It is manufactured by Graham Medical Technologies, LLC Dba Gramedica. The 510(k) number is K162179.

When was osteo-WEDGE II ® Open Wedge Bone Locking Plate System approved by the FDA?

osteo-WEDGE II ® Open Wedge Bone Locking Plate System received FDA 510(k) clearance on 2017-01-10, under approval number K162179.

What company makes osteo-WEDGE II ® Open Wedge Bone Locking Plate System?

osteo-WEDGE II ® Open Wedge Bone Locking Plate System is manufactured by Graham Medical Technologies, LLC Dba Gramedica.

What is the FDA product code for osteo-WEDGE II ® Open Wedge Bone Locking Plate System?

The FDA product code for osteo-WEDGE II ® Open Wedge Bone Locking Plate System is HRS.

Related Clinical Trials

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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.

↑