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FDA 510(k)

ORTHOLOC SPS Shoulder Plating System

K-Number: K181587 · 2018-10-05

ApplicantTornier, Inc.
Decision Date2018-10-05
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOLOC SPS Shoulder Plating System is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2018-10-05 under approval number K181587. 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 SPS Shoulder Plating System?

ORTHOLOC SPS Shoulder Plating System is a medical device that received FDA 510(k) clearance on 2018-10-05. It is manufactured by Tornier, Inc.. The 510(k) number is K181587.

When was ORTHOLOC SPS Shoulder Plating System approved by the FDA?

ORTHOLOC SPS Shoulder Plating System received FDA 510(k) clearance on 2018-10-05, under approval number K181587.

What company makes ORTHOLOC SPS Shoulder Plating System?

ORTHOLOC SPS Shoulder Plating System is manufactured by Tornier, Inc..

What is the FDA product code for ORTHOLOC SPS Shoulder Plating System?

The FDA product code for ORTHOLOC SPS Shoulder Plating System is HRS.

Related Clinical Trials

NCT04816825 Home-monitored Telerehabilitation in COPD Patients COMPLETED NCT05951491 Improving Arm Function Using Wearable Exoskeletons SUSPENDED NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING NCT07550543 PEMF Therapy in Shoulder Tendinopathy RECRUITING NCT07421245 OsseoFit Stemless Shoulder System (Anatomic) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026)

Other Devices by Tornier, Inc.

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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.

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