ClearanceBrief
Panels › General, Plastic Surgery › Product code FZX · Class 1

Guide, Surgical, Instrument

Regulation 878.4800

0510(k)s in 12 months (19 all time)
0recalls in 12 months (29 all time)
2recalls that name a 510(k)
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Top companies in FZX

DateFirm and productCodeLinked 510(k)
Dec 11, 2024Hologic, Inc
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
Completed
FZXNone listed
Jan 18, 2024Waldemar Link GmbH & Co. KG (Mfg Site)
Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
Open, Classified
FZXNone listed
Aug 21, 2019Zimmer Biomet, Inc.
2.0MM BALL NOSE GUIDE WIRE, Item Nos. 281017006 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Terminated
FZXNone listed
Aug 21, 2019Zimmer Biomet, Inc.
BALL NOSE GUIDE WIRE 80CM, 100CM. Item Nos. 281001080 281001100 Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Terminated
FZXNone listed
Aug 21, 2019Zimmer Biomet, Inc.
GUIDE WIRE 2.2MM X 28IN, Aim/Art Guide wire, Item No. 809222028 - Product Usage: These instruments and delivery systems are used to facilitate implantation of orthopedic medical devices.
Terminated
FZXNone listed
Mar 26, 2018Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
Terminated
FZXNone listed
Aug 7, 2017Synthes, Inc.
LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
Terminated
FZXNone listed
Apr 25, 2017Cook Inc.
Endoscopic Introducer/Extractor
Terminated
FZXNone listed
Oct 14, 2016Zimmer Biomet, Inc.
Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted in
Terminated
FZXNone listed
Jul 15, 2016Synthes (USA) Products LLC
Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw Guide Sleeve, Surgical Instrument Part Number ID 03.037.017, Class I exempt Lot Numbers: 9066399; 9066435; 9409790; 951930
Terminated
FZXNone listed
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. guide, surgical, instrument
Terminated
FZXNone listed
Feb 16, 2016Synthes (USA) Products LLC
Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
Terminated
FZXNone listed
Sep 30, 2015Zimmer, Inc.
Zimmer Guide Wires for orthopedic procedures.
Terminated
FZXNone listed
Aug 24, 2015Omnilife Science Inc.
Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip System
Terminated
FZXNone listed
Aug 24, 2015Omnilife Science Inc.
Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Syste
Terminated
FZXNone listed
Jun 19, 2015Orthofix, Inc
ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
Terminated
FZXNone listed
Jun 15, 2015Synthes, Inc.
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleeve and plate holes to pull or push bone fragments relative to th
Terminated
FZXNone listed
Mar 16, 2015Synthes, Inc.
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part nu
Terminated
FZXNone listed
Aug 1, 2014X Spine Systems Inc
Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion
Terminated
FZXNone listed
Feb 19, 2014Synthes, Inc.
Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and
Terminated
FZXNone listed
Dec 27, 2013Zimmer, Inc.
ITST THREADED GUIDE PIN
Terminated
FZXK082078
Dec 6, 2013Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disa
Terminated
FZXNone listed
Dec 6, 2013Zimmer, Inc.
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only Devices are used in total knee arthroplasty and indicated for patients with severe pain and disa
Terminated
FZXNone listed
Nov 22, 2013Biomet, Inc.
REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
Terminated
FZXNone listed
Aug 2, 2013SpineFrontier, Inc.
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protect
Terminated
FZXK071420
Sep 14, 2012Integra Life Sci.
The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix Locking Screw with plates for the Tiblaxis, Uni-
Terminated
FZXNone listed
Oct 20, 2011Biomet, Inc.
MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA. This device is used to mark the femoral neck resection level
Terminated
FZXNone listed
Mar 28, 2011Biomet, Inc.
REF 32-485050 VANGUARD KNEE INSTRUMENTATION MICROPLASTY SLIDEX ANTERIOR/POSTERIOR, QTY: 1 The guide is used for femoral sizing - Neutral or 3 degree femoral rotation feet are attached to the slidex
Terminated
FZXNone listed
Nov 19, 2009Biomet, Inc.
Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534. Internal fixation devices intended to aid in th
Terminated
FZXNone listed

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