ClearanceBrief
Panels › Orthopedic › Product code KWT · Class 2

Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Regulation 888.3650

2510(k)s in 12 months (72 all time)
0recalls in 12 months (31 all time)
28recalls that name a 510(k)
Get daily alerts for KWTSample briefCSV

Top companies in KWT

DateFirm and productCodeLinked 510(k)
Jan 18, 2024Exactech, Inc.
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j)
Open, Classified
KWTK063569
K093275 +2
Oct 10, 2019Zimmer Biomet, Inc.
Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 32855090265 32855090266 32855090270 32855090287 32855090290 32855090291 32855090297 32855090302 32855090317 32855090318 3285509031
Terminated
KWTNone listed
Oct 10, 2019Zimmer Biomet, Inc.
Trabecular Metal Reverse Shoulder System, Item Nos. 00434210613 00430900103 00434210613 00434210813 00434210817 00434210913 00434211013 00434211017 00434211113 00434211213 00434211217 00434211313 0043
Terminated
KWTK130661
Oct 10, 2019Zimmer Biomet, Inc.
BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00
Terminated
KWTK982981
Aug 21, 2018Exactech, Inc.
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Open, Classified
KWTK063569
Mar 23, 2018Biomet, Inc.
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
Terminated
KWTK111746
Sep 22, 2017Zimmer Biomet, Inc.
Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
Terminated
KWTK052906
Jun 5, 2017Zimmer Biomet, Inc.
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Terminated
KWTK023063
Oct 25, 2016Exactech, Inc.
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Terminated
KWTK063569
Sep 2, 2015Limacorporate S.p.A
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm
Terminated
KWTK100858
Feb 26, 2014Zimmer, Inc.
00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1,
Terminated
KWTK041549
Feb 24, 2014Zimmer, Inc.
Trabecular Metal" Reverse Shoulder System
Terminated
KWTK052906
Dec 30, 2013Zimmer, Inc.
Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheum
Terminated
KWTK130661
Aug 26, 2013Zimmer, Inc.
00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenospher
Terminated
KWTK052906
Dec 5, 2012Biomet, Inc.
Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during th
Terminated
KWTK030710
Nov 6, 2012Zimmer, Inc.
Zimmer Inverse/Reverse Screw system,
Terminated
KWTNone listed
Jul 31, 2012Exactech, Inc.
Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Terminated
KWTK102951
Jul 31, 2012Exactech, Inc.
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Terminated
KWTK063569
Jun 27, 2012Zimmer, Inc.
Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
Terminated
KWTK103404
Dec 9, 2010Zimmer Inc.
Zimmer Trabecular Metal Reverse Shoulder System Surgical Technique. Catalog Number 97-4309-003-00, Rev. 4. The Zimmer Trabecular Metal Reverse Shoulder System is a treatment option for patients with s
Terminated
KWTK041549
K050761 +2
Dec 9, 2010Zimmer Inc.
Zimmer Trabecular Metal Humeral Stem 4-Part Fracture Surgical Technique. Catalog Number 97-4309-004-00, Rev. 3. The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi
Terminated
KWTK041549
K050761 +2
Dec 9, 2010Zimmer Inc.
Zimmer Trabecular Metal Humeral Stem Surgical Technique. Catalog Number: 97-4309-002-00, Rev. 3 The Zimmer Trabecular Metal Shoulder System consists of conventional and reverse, semi- and nonconstrai
Terminated
KWTK041549
K050761 +2
Dec 9, 2010Zimmer Inc.
TRABECULAR METAL" SHOULDER REAMER CASE used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4312-020-00. The intramed
Terminated
KWTK041549
K050761 +2
Dec 9, 2010Zimmer Inc.
BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Numbe
Terminated
KWTNone listed
Dec 9, 2010Zimmer Inc.
ZIMMER TRABECULAR METAL" SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-
Terminated
KWTK050761
K052906 +1
Dec 9, 2010Zimmer Inc.
ZIMMER TRABECULAR METAL SHOULDER INSTRUMENTATION, DISTAL PILOT used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4
Terminated
KWTK041549
K050761 +2
Sep 16, 2008Biomet, Inc.
Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to fu
Terminated
KWTK060694
Aug 26, 2006Zimmer Inc.
Zimmer Trabecular Metal Reverse Shoulder System Base Plate; Catalog/Ref No. 00-4349-038-00.
Terminated
KWTK052906
Aug 26, 2006Zimmer Inc.
Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 40 mm diameter; Catalog/Ref No. 00-4349-040-01.
Terminated
KWTK052906
Aug 26, 2006Zimmer Inc.
Zimmer Trabecular Metal Reverse Shoulder System Glenosphere, 36 mm diameter; Catalog/Ref No. 00-4349-036-01.
Terminated
KWTK052906
Jul 20, 2004Biomet, Inc.
Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
Terminated
KWTK002998

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.