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FDA 510(k)

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE

K-Number: K121601 · 2012-07-06

ApplicantSynthes USA
Decision Date2012-07-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Synthes USA. It received FDA 510(k) clearance on 2012-07-06 under 510(k) number K121601. 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 SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE?

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE is a medical device that received FDA 510(k) clearance on 2012-07-06. The listed applicant is Synthes USA. The 510(k) number is K121601.

When did SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE receive FDA 510(k) clearance?

SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE received FDA 510(k) clearance on 2012-07-06, under 510(k) number K121601.

Who is the listed applicant for SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE?

The FDA 510(k) record lists Synthes USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE?

The FDA product code for SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE is HRS.

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Other records listing Synthes USA 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.

K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTSK111540SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

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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

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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