ORTHOLOC® 3Di Small Bones Plating
K-Number: K163039 · 2017-03-13
ApplicantWrightmedicaltechnologyinc
Decision Date2017-03-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
ORTHOLOC® 3Di Small Bones Plating is a medical device manufactured by Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-03-13 under approval number K163039. 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 ORTHOLOC® 3Di Small Bones Plating?
ORTHOLOC® 3Di Small Bones Plating is a medical device that received FDA 510(k) clearance on 2017-03-13. It is manufactured by Wrightmedicaltechnologyinc. The 510(k) number is K163039.
When was ORTHOLOC® 3Di Small Bones Plating approved by the FDA?
ORTHOLOC® 3Di Small Bones Plating received FDA 510(k) clearance on 2017-03-13, under approval number K163039.
What company makes ORTHOLOC® 3Di Small Bones Plating?
ORTHOLOC® 3Di Small Bones Plating is manufactured by Wrightmedicaltechnologyinc.
What is the FDA product code for ORTHOLOC® 3Di Small Bones Plating?
The FDA product code for ORTHOLOC® 3Di Small Bones Plating is HRS.
Other Devices by Wrightmedicaltechnologyinc
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.