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)
Top companies in FZX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 11, 2024 | Hologic, Inc Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide
Model/Catalog Number: F0101 Completed |
FZX | None listed |
| Jan 18, 2024 | Waldemar 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 |
FZX | None listed |
| Aug 21, 2019 | Zimmer 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 |
FZX | None listed |
| Aug 21, 2019 | Zimmer 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 |
FZX | None listed |
| Aug 21, 2019 | Zimmer 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 |
FZX | None listed |
| Mar 26, 2018 | Zimmer 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 |
FZX | None listed |
| Aug 7, 2017 | Synthes, 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 |
FZX | None listed |
| Apr 25, 2017 | Cook Inc. Endoscopic Introducer/Extractor Terminated |
FZX | None listed |
| Oct 14, 2016 | Zimmer 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 |
FZX | None listed |
| Jul 15, 2016 | Synthes (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 |
FZX | None listed |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
guide, surgical, instrument Terminated |
FZX | None listed |
| Feb 16, 2016 | Synthes (USA) Products LLC Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument Terminated |
FZX | None listed |
| Sep 30, 2015 | Zimmer, Inc. Zimmer Guide Wires for orthopedic procedures. Terminated |
FZX | None listed |
| Aug 24, 2015 | Omnilife 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 |
FZX | None listed |
| Aug 24, 2015 | Omnilife 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 |
FZX | None listed |
| Jun 19, 2015 | Orthofix, 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 |
FZX | None listed |
| Jun 15, 2015 | Synthes, 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 |
FZX | None listed |
| Mar 16, 2015 | Synthes, 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 |
FZX | None listed |
| Aug 1, 2014 | X 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 |
FZX | None listed |
| Feb 19, 2014 | Synthes, 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 |
FZX | None listed |
| Dec 27, 2013 | Zimmer, Inc. ITST THREADED GUIDE PIN Terminated |
FZX | K082078 |
| Dec 6, 2013 | Zimmer, 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 |
FZX | None listed |
| Dec 6, 2013 | Zimmer, 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 |
FZX | None listed |
| Nov 22, 2013 | Biomet, 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 |
FZX | None listed |
| Aug 2, 2013 | SpineFrontier, 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 |
FZX | K071420 |
| Sep 14, 2012 | Integra 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 |
FZX | None listed |
| Oct 20, 2011 | Biomet, 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 |
FZX | None listed |
| Mar 28, 2011 | Biomet, 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 |
FZX | None listed |
| Nov 19, 2009 | Biomet, 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 |
FZX | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.