ClearanceBrief
Panels › Orthopedic › Product code HWC · Class 2

Screw, Fixation, Bone

Regulation 888.3040

22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
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Top companies in HWC

DateFirm and productCodeLinked 510(k)
May 12, 2017DePuy Mitek, Inc., a Johnson & Johnson Co.
DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the antero
Terminated
HWCK083096
K091694 +1
Mar 9, 2017Smith & Nephew, Inc.
D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692412 (c) 2.4MM X 16MM, RES 74692416 (d) 2.4MM X 22MM, RES 74692422
Terminated
HWCK132296
Mar 9, 2017Smith & Nephew, Inc.
D-RAD, 2.4MMX 20MM, S.T. CORTEX SCREW, QTY: (1), STERILE R, RES 74682420 Orthopedic
Terminated
HWCK132296
Mar 9, 2017Smith & Nephew, Inc.
D-RAD, 1.8MM X 16MM, LOCKING PEG, QTY: (1), STERILE R, RES 74671816 Orthopedic
Terminated
HWCK132296
Jan 10, 2017Zimmer Biomet, Inc.
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Terminated
HWCK121589
Jan 6, 2017Trilliant Surgical Ltd.
Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of
Terminated
HWCK153338
Nov 17, 2016Trilliant Surgical Ltd.
Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
Terminated
HWCK112737
Nov 8, 2016Wright Medical Technology, Inc.
Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S
Terminated
HWCNone listed
Nov 8, 2016Wright Medical Technology, Inc.
ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538
Terminated
HWCK102429
Sep 19, 2016OrthoPediatrics Corp
3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in
Terminated
HWCK083286
Sep 19, 2016OrthoPediatrics Corp
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and in
Terminated
HWCK083286
Jul 21, 2016Integra LifeSciences Corp.
Large QWIX Compression screw, dia. 7.5 mm L 90 mm, Lot No. FH86, Rx only, Product Usage: The QWIX Positioning screw is indicated for fixation of bone fractures or for bone reconstruction.
Terminated
HWCK071639
Jul 21, 2016Ortho Solutions Inc
FPS 35mm x 3.5 mm non-locking screw
Terminated
HWCK111678
Jul 11, 2016Synthes (USA) Products LLC
3.5 mm and 4.0 mm Cannulated Screw, Product code HWC, Device Listing Number D029094, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such a
Terminated
HWCK021932
Jul 11, 2016Synthes (USA) Products LLC
4.5 mm Cannulated Screw, Product code HWC, Device Listing Number D029092 and D120718, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such
Terminated
HWCK021932
Jul 11, 2016Synthes (USA) Products LLC
4.5 mm Cortex Screw, Product code HWC, Device Listing Number D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral neck
Terminated
HWCK021932
Jul 11, 2016Synthes (USA) Products LLC
4.0 mm Cortex Screw, Product code HWC, Device Listing Number D137404 and D137402, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as f
Terminated
HWCK021932
Jul 11, 2016Synthes (USA) Products LLC
7.0 mm and 7.3 mm Cannulated Screw, Product code HWC, Device Listing Number D068620, Plate, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such a
Terminated
HWCK021932
Jul 11, 2016Synthes (USA) Products LLC
6.5 mm Cancellous Screw, Product code HWC, Device Listing Number D029043, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral n
Terminated
HWCK021932
Jul 11, 2016Synthes (USA) Products LLC
6.5 mm Cannulated Screw, Product code HWC, Device Listing Number D028949, Screw, Fixation Bone Product Usage: Intended for fracture fixation of large bones and large bone fragments, such as femoral n
Terminated
HWCK021932
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
Terminated
HWCK992367
May 16, 2016Zimmer Manufacturing B.V.
Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 47115504507 Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 75 mm Length 47115507507 Herbert Cannulated Bone
Terminated
HWCK143165
May 16, 2016Zimmer Manufacturing B.V.
Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bon
Terminated
HWCK142442
May 16, 2016Zimmer Manufacturing B.V.
Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 4.0 mm Cancellous Screw Fully Thread
Terminated
HWCK112885
May 16, 2016Zimmer Manufacturing B.V.
Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116
Terminated
HWCK111447
May 16, 2016Zimmer Manufacturing B.V.
Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
Terminated
HWCK082527
May 16, 2016Zimmer Manufacturing B.V.
Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
Terminated
HWCK063303
May 16, 2016Zimmer Manufacturing B.V.
Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 3.5 mm Cortical Screw SelfTapping, 16 mm Lengt
Terminated
HWCK060710
May 6, 2016MicroAire Surgical Instruments, LLC
Endotine Transbleph 3.5 (CFD-080-0167)
Terminated
HWCK042796
Apr 18, 2016Stryker Howmedica Osteonics Corp.
VariAx Compression Plating System
Terminated
HWCK130009
Apr 4, 2016Synthes (USA) Products LLC
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Terminated
HWCK041533
Mar 12, 2016Zimmer Manufacturing B.V.
Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 4
Terminated
HWCK111447
Mar 12, 2016Zimmer Manufacturing B.V.
Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOM
Terminated
HWCNone listed
Mar 12, 2016Zimmer Manufacturing B.V.
Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024
Terminated
HWCK142442
Mar 12, 2016Zimmer Manufacturing B.V.
Product 44 consists of all product under product code: HWC and same usage: Item no: 114607099 MAGMA-FX CANN SCREW 7.0MM 114604099 MAGNA FX CANN SCREW 7.0MM 114603000 MAGNA-FX CANN SCREW 7.0MM 114603
Terminated
HWCK142442
Mar 12, 2016Zimmer Manufacturing B.V.
Product 32 consists of all product under product code: HWC and same usage: Item no: 47115401200 HERBERT BONE SCREW, 3.0MM 47115401400 HERBERT BONE SCREW, 3.0MM 47115401600 HERBERT BONE SCREW, 3.0MM
Terminated
HWCK143165
Mar 12, 2016Zimmer Manufacturing B.V.
Product 18 consists of all product under product code: HWC and same usage: Item no: 47248001441 CANC SCR 4.0MM X 14MM FUL 47248001641 CANC SCR 4.0MM X 16MM FUL 47248001840 CANC SCR 4.0MM X 18MM 4724
Terminated
HWCK112885
Mar 12, 2016Zimmer Manufacturing B.V.
Product 13 consists of all product under product code HWC , and same usage: Item no: 47486510002 6.5 X 100 CANC SCREW, 32M Product Usage: A smooth or threaded metallic bone fixation fastener is a de
Terminated
HWCK112885
Mar 12, 2016Zimmer Manufacturing B.V.
Product 10consists of all product under product code HWC, and same usage: Item no: 47484502601 4.5 X 26 CORT SCREW SELF Product Usage: A smooth or threaded metallic bone fixation fastener is a de
Terminated
HWCK112885
Mar 12, 2016Zimmer Manufacturing B.V.
Product 8 consists of all products under product code HWC, and same usage: Item no: 47483501201 3.5MM CORT. SCREW 12MM LN 47483501401 3.5MM CORT. SCREW 14MM LN 47483501601 3.5MM CORT. SCREW 16MM LN 4
Terminated
HWCK060710
Mar 12, 2016Zimmer Manufacturing B.V.
Product 7 consists of all products under product code HWC, and same usage: Item no: 47234801435 3.5MM CORT SCR X 14MM 47234801635 3.5MM CORT SCR X 16MM 47234806535 3.5MM CORT SCR X 65MM 47234807035
Terminated
HWCK111447
Mar 12, 2016Zimmer Manufacturing B.V.
Product 6 consists of all products under product code HWC, and same usage: Item no: 47493501001 3.5 X 10 CORT SCREW SELFT 47493501801 3.5 X 18 CORT SCREW SELFT Product Usage: A smooth or threaded m
Terminated
HWCK082527
Mar 12, 2016Zimmer Manufacturing B.V.
Product 5 consists of all products under product code HWC, and same usage: Item no: 47482701001 2.7MM CORT. SCREW 10MM, S 47482701201 2.7MM CORT. SCREW 12MM, S 47482701401 2.7MM CORT. SCREW 14MM,
Terminated
HWCK063303
Mar 12, 2016Zimmer Manufacturing B.V.
Product 4 consists of all products under product code HWC, and same usage: Item no: 47482002603 2.0 X 26 CORT SCREW CRUCI 47482002803 2.0 X 28 CORT SCREW CRUCI 47482003203 2.0 X 32 CORT SCREW CRUCI
Terminated
HWCK112885
Mar 12, 2016Zimmer Manufacturing B.V.
Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/SE Product Usage: A smooth or threaded metallic bone fixation fastener is a de
Terminated
HWCNone listed
Dec 9, 2015Zimmer Biomet, Inc.
Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and
Terminated
HWCK040593
K042598
Dec 9, 2015In2Bones, SAS
IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Terminated
HWCK131920
Nov 20, 2015Pega Medical Inc.
SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This
Terminated
HWCK131591
Nov 2, 2015Synthes (USA) Products LLC
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly
Terminated
HWCK012114
K040588 +4
Oct 6, 2015Ortho Solutions Inc
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone
Terminated
HWCK141784

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