Product Code: HWC


Products Classified as HWC

4489Screw, Fixation, BoneSmooth Or Threaded Metallic Bone Fixation Fastener.

Total Product Life Cycle (TPLC) Devices

4489Screw, Fixation, BoneSmooth Or Threaded Metallic Bone Fixation Fastener.

FDA Consensus Standards

Screw, Fixation, Bone [34059]21 CFR §888.3040 🔎
Screw, Fixation, Bone [34070]21 CFR §888.3040 🔎
Screw, Fixation, Bone [37410]21 CFR §888.3040 🔎
Screw, Fixation, Bone [37411]21 CFR §888.3040 🔎
Screw, Fixation, Bone [37861]21 CFR §888.3040 🔎
Screw, Fixation, Bone [37390]21 CFR §888.3040 🔎
Screw, Fixation, Bone [34069]21 CFR §888.3040 🔎
Screw, Fixation, Bone [30912]21 CFR §888.3040 🔎
Screw, Fixation, Bone [37432]21 CFR §888.3040 🔎
Screw, Fixation, Bone [35572]21 CFR §888.3040 🔎
Screw, Fixation, Bone [37813]21 CFR §888.3040 🔎

Pre-market Notifications for HWC

K222967Avanti Orthopaedics 2.2mm And 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm And 4.0mm Cannulated ScrewsAvanti Orthopaedics, Inc.
K222505CurvaFix IM SystemCurvaFix, Inc.
K222409CAPTIVATE® Compression ScrewsGlobus Medical, Inc.
K221610Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.
K220892ExsoMed INnate NanoTM Lag Screw SystemExsoMed Corp.
K220723Hand Trauma Screw SystemSkeletal Dynamics, Inc.
K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH
K213614Cannulated ScrewsMaxxion Medical, LLC
K213596OSSIOfiber Compression Screw, 3.5mmOSSIO Ltd.
K213572JuniOrtho Plating Systemâ„¢Orthofix Srl
K213530Nextra CH Cannulated Hammertoe SystemNextremity Solutions, Inc.
K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc
K213199Asnis® III Cannulated Screw System And Asnis® PRO Cannulated Screw SystemStryker GmbH
K213036Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.
K212996Sterile PHALINX Hammertoe SystemWright Medical Technology, Inc.

Global Unique Device Identification Database

20613994471561Screw, fixation, bone
20613994471523Screw, fixation, bone
20613994471516Screw, fixation, bone
00613994106834Screw, fixation, bone
00613994106827Screw, fixation, bone
20613994106814Screw, fixation, bone
20613994106807Screw, fixation, bone
00643169620575Screw, fixation, bone
00643169620568Screw, fixation, bone
00643169620551Screw, fixation, bone
00643169620544Screw, fixation, bone
00643169590311Screw, fixation, bone
00643169497931Screw, fixation, bone
00643169497924Screw, fixation, bone
00643169497917Screw, fixation, bone

Maude Adverse Events

UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNKNOWN PROXIMAL SCREWSTRYKER TRAUMA KIEL2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: 2.4 MM AND 3.0 MM HEADLESS COMPRESSIONOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
VERSALOK PRE PACKED W/OCDEPUY MITEK LLC US2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CANNULATEDOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: MATRIXNEUROWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CORTEXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CORTEXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CORTEXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CORTEXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CORTEXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CORTEXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: CORTEXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 34MM FOR IM NAILSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 42MM FOR IM NAILSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
SCR BIORCI-HA 9X30 STERILESMITH & NEPHEW, INC.2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 60MM FOR IM NAILSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - SCREWS: TRAUMAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 56MM FOR IM NAILSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNKNOWN COMPRESSION SCREWSTRYKER GMBH2020-03-30
UNKNOWN LOCKING SCREWSTRYKER GMBH2020-03-30
UNK - SCREWS: CANNULATEDWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
UNK - SCREWS: CANNULATEDWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
UNK - SCREWS: LOCKINGOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-30

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