FDA 510(k)

INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW

K-Number: K080434 · 2008-04-10

Decision Date2008-04-10

Product CodeJDO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2008-04-10 under 510(k) number K080434. The device is classified under product code JDO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW?

INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW is a medical device that received FDA 510(k) clearance on 2008-04-10. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K080434.

When did INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW receive FDA 510(k) clearance?

INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW received FDA 510(k) clearance on 2008-04-10, under 510(k) number K080434.

Who is the listed applicant for INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW?

The FDA product code for INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW is JDO.

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Related Devices (Code: JDO)

K230764OsteoCentric Integrated Hip Fastener SystemOsteoCentric Technologies K213126Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screwsSmith & Nephew, Inc.K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma K193029CONQUEST FNSmith & Nephew, Inc.K173826THP Hip Fracture Plating SystemBiomet, Inc.K172785CONQUEST FNSmith & Nephew

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.