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

K211996Nexta PEEK Hammertoe Correction SystemNextremity Solutions, Inc.
K211944Medline UNITE® Digital Fusion Screw SystemMedline Industries, Inc.
K211783TriMed Threaded Intramedullary Nail SystemTriMed, Inc.
K211435PAO Cortical ScrewMedacta International SA
K211261Axis Charcot Fixation SystemExtremity Medical, LLC.
K210754Cannulated Fasteners And NutsOsteoCentric Technologies
K210792Auxein Nailing SystemAuxein Medical Private Limited
K210268LTJ Screws And WasherAzurMeds Inc.
K210159IntraLock SystemFusion Orthopedics, LLC
K203467WishBone Medical Plate And Screw SystemWishBone Medical, Inc.
K203381Dynanail Mini HybridMedShape Inc
K203239Arthrex Low Profile ScrewsArthrex Inc.
K203105Inion CompressOn ScrewInion Oy
K203029Auxilock Titanium Interference ScrewAuxein Medical Private Limited
K202817GEO Bone Screw SystemGramercy Extremity Orthopedics, LLC

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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