Medical Device Manufacturer · US , Warsaw , IN

Biomet Manufacturing Corp

93 submissions · 93 cleared · Since 2004
93
Total
93
Cleared
0
Denied

Biomet Manufacturing Corp — FDA 510(k) Submissions

Biomet Manufacturing Corp has submitted 93 FDA 510(k) premarket notifications since 2004, of which 93 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component), Shoulder Prosthesis, Reverse Configuration, Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer, Fastener, Fixation, Nondegradable, Soft Tissue, Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented . Use the specialty filter in the sidebar to narrow results.

93 devices
1–25 of 93
Patient Specific Planning Solution? 3D Bone Models
K230540 · LLZ System, Image Processing,... · Radiology
Jul 2023 148d
Comprehensive? Shoulder System, Comprehensive? Reverse Shoulder System
K214001 · PHX Shoulder Prosthesis,... · Orthopedic
Mar 2023 449d
Comprehensive? Convertible Glenoid - Vivacit-E Liner
K211729 · PHX Shoulder Prosthesis,... · Orthopedic
Nov 2021 153d
Comprehensive Vault Reconstruction System
K202232 · PHX Shoulder Prosthesis,... · Orthopedic
Feb 2021 196d
Comprehensive Shoulder System
K193038 · MBF Prosthesis, Shoulder,... · Orthopedic
Oct 2020 363d
Comprehensive Nano Stemless Shoulder
K182516 · PKC Prosthesis, Total... · Orthopedic
Apr 2019 221d
Comprehensive Reverse Shoulder System
K181611 · PHX Shoulder Prosthesis,... · Orthopedic
Sep 2018 97d
Comprehensive Segmental Revision System (SRS)
K173411 · PHX Shoulder Prosthesis,... · Orthopedic
Feb 2018 99d
Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
K172502 · PHX Shoulder Prosthesis,... · Orthopedic
Jan 2018 138d
ExpressBraid Graft Manipulation
K163651 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Feb 2017 56d
COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
K152754 · PHX Shoulder Prosthesis,... · Orthopedic
May 2016 235d
Ventix Suture Anchor
K153558 · MBI Fastener, Fixation,... · Orthopedic
Apr 2016 129d
Ventix Knotless Anchors
K152262 · MBI Fastener, Fixation,... · Orthopedic
Mar 2016 210d
ExpressBraid Graft Manipulation
K152868 · GAT Suture, Nonabsorbable,... · General & Plastic Surgery
Feb 2016 131d
Comprehensive SRS/Nexel Elbow
K153398 · JDC Prosthesis, Elbow,... · Orthopedic
Feb 2016 71d
TiTHON Staple with OsseoTi Technology
K151615 · JDR Staple, Fixation, Bone · Orthopedic
Oct 2015 109d
JuggerKnot Soft Anchors
K150768 · MBI Fastener, Fixation,... · Orthopedic
Sep 2015 164d
JuggerStitch Meniscal Repair Device
K150424 · MBI Fastener, Fixation,... · Orthopedic
May 2015 85d
SnapShot Fixation System
K143037 · JDR Staple, Fixation, Bone · Orthopedic
Jan 2015 90d
3.Omm Biomet Cannulated Screw System
K143188 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2014 55d
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
K141263 · JDR Staple, Fixation, Bone · Orthopedic
Nov 2014 188d
Biomet Headless Compression and Twist-off Screws
K142658 · HWC Screw, Fixation, Bone · Orthopedic
Nov 2014 56d
TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS
K140390 · MBF Prosthesis, Shoulder,... · Orthopedic
Sep 2014 208d
JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS
K141219 · HTN Washer, Bolt Nut · Orthopedic
Jul 2014 67d
POROUS COATED COMPREHENSIVE FRACTURE STEMS
K140652 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2014 111d

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