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)

Smith & Nephew Plates and Screws

K-Number: K210837 · 2021-06-29

ApplicantSmith & Nephew, Inc.
Decision Date2021-06-29
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Smith & Nephew Plates and Screws is a medical device manufactured by Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2021-06-29 under approval number K210837. 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 Smith & Nephew Plates and Screws?

Smith & Nephew Plates and Screws is a medical device that received FDA 510(k) clearance on 2021-06-29. It is manufactured by Smith & Nephew, Inc.. The 510(k) number is K210837.

When was Smith & Nephew Plates and Screws approved by the FDA?

Smith & Nephew Plates and Screws received FDA 510(k) clearance on 2021-06-29, under approval number K210837.

What company makes Smith & Nephew Plates and Screws?

Smith & Nephew Plates and Screws is manufactured by Smith & Nephew, Inc..

What is the FDA product code for Smith & Nephew Plates and Screws?

The FDA product code for Smith & Nephew Plates and Screws is HRS.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT03720782 Safety and Performance Study of the Legion Porous System in Total Knee Arthroplasty ACTIVE_NOT_RECRUITING

Other Devices by Smith & Nephew, Inc.

K163086VLP MINI-MOD 2.0mm Column Plates K161233OXINIUM DH Fermoral Heads K161264TRIGEN Low Profile Bone Screws K161763Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device K162078EVOS Small Fragment Plating System K160923REDAPT Anteverted Cemented Liner

View all 107 devices →

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.

↑