TSP HIP FRACTURE PLATING SYSTEM— 510(k) K140018

Clearance details

Applicant

Biomet, Inc.

Product code

Code JDO

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2014-01-03

Decision date

2014-04-04

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

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• Z-1347-2020 — THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.Class II·Terminated·Zimmer Biomet, Inc.·20200107
• Z-2240-2016 — TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochanteric fractures. Fracture plates with six or more femoral shaft fixation screw holes are also indicated for subtrochanteric fractures as well as proximal femoral osteotomiesClass II·Terminated·Biomet, Inc.·20160610

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140018.