HSB

Product Code: HSB


Products Classified as HSB

4467Rod, Fixation, Intramedullary And AccessoriesIntramedullary Fixation Rod.

Total Product Life Cycle (TPLC) Devices

4467Rod, Fixation, Intramedullary And AccessoriesIntramedullary Fixation Rod.

FDA Consensus Standards

Rod, Fixation, Intramedullary And Accessories [37410]21 CFR §888.3020 ๐Ÿ”Ž
Rod, Fixation, Intramedullary And Accessories [37411]21 CFR §888.3020 ๐Ÿ”Ž
Rod, Fixation, Intramedullary And Accessories [37431]21 CFR §888.3020 ๐Ÿ”Ž
Rod, Fixation, Intramedullary And Accessories [37812]21 CFR §888.3020 ๐Ÿ”Ž
Rod, Fixation, Intramedullary And Accessories [37449]21 CFR §888.3020 ๐Ÿ”Ž
Rod, Fixation, Intramedullary And Accessories [34719]21 CFR §888.3020 ๐Ÿ”Ž

Pre-market Notifications for HSB

K221489Artemis Proximal Femoral Nail SystemGLW, Inc.
K221115Flow-NailFlow-FX, LLC
K220679Pediatric Nailing Platform FemurOrthoPediatrics Corp.
K220659AUTOBAHN(R) EVO Femoral NailsGlobus Medical Inc.
K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH
K212030Flex-Threadโ„ข Distal Fibula Lntramedullary Nail SystemFlower Orthopedics Corporation DBA Conventus Flower
K211292Fassier-Duval Telescopic IM SystemPega Medical Inc.
K210285Adaptable Ortho Innovations Intramedullary Nail SystemAdaptable Ortho Innovations, LLC
K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail SystemStryker GmbH
K203811GPC Intraheal Intramedullary Nailing SystemGPC Medical Limited
K203399FITBONE(R) TAAWITTENSTEIN Intens GmbH
K202935Syntec Femoral Nail Extended SystemSyntee Scientific Corporation
K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC
K202099AOS Galileoโ„ข Trochanteric Nail SystemAdvanced Orthopaedic Solutions, Inc.
K201830ANSER Clavicle PinBaat Medical Products BV

Global Unique Device Identification Database

00814289020761Rod, Fixation, Intramedullary And Accessories
00814289020433Rod, Fixation, Intramedullary And Accessories
00814289020044Rod, Fixation, Intramedullary And Accessories
00814289020037Rod, Fixation, Intramedullary And Accessories
00814289020020Rod, Fixation, Intramedullary And Accessories
00814289020013Rod, Fixation, Intramedullary And Accessories
00814289020006Rod, Fixation, Intramedullary And Accessories
00812258029234Rod, Fixation, Intramedullary And Accessories
00812258029227Rod, Fixation, Intramedullary And Accessories
00812258029210Rod, Fixation, Intramedullary And Accessories
00812258029203Rod, Fixation, Intramedullary And Accessories
00812258029180Rod, Fixation, Intramedullary And Accessories
00812258029173Rod, Fixation, Intramedullary And Accessories
00812258029128Rod, Fixation, Intramedullary And Accessories
00812258028916Rod, Fixation, Intramedullary And Accessories

Maude Adverse Events

UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
TROCHANTERIC NAIL KIT, STST GAMMA3? ?11X180MM X 130?STRYKER TRAUMA KIEL2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
HUMERAL NAIL T2 HUMERUS ?9X200 MMSTRYKER TRAUMA KIEL2020-03-31
9 MM / TI CANN FRN / GT 420MM / LEFT - STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
PFNA-II 10 LONG LE 125 L320 TANOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
12MM/130 DEG TI CANN TFNA 420MM/LEFT-STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNKNOWN POLYETHYLENE INSERT 6MMSTRYKER GMBH2020-03-31
GREATER TROCHANTER FEMORAL NAIL - GREEN LEFTZIMMER BIOMET, INC.2020-03-31
4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODSOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-30
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEMNUVASIVE SPECIALIZED ORTHOPEDICS, INC.2020-03-30
PRECICE STRYDE SYSTEMNUVASIVE SPECIALIZED ORTHOPEDICS, INC.2020-03-30
PFNA-II BLADE L95 TANOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-30
HELICAL BLADE INSERTERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM F/IM NAIL-STERWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
UNK - NAILS: TFNAWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-29
UNK - NAIL HEAD ELEM: TFN LAG SCREWWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-29
UNK - NAILS: TFNWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-29
UNK - NAIL HEAD ELEMENTS: PFNA-II BLADEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - CONSTRUCTS: EXPERT TIBIAL NAILOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - NAIL HEAD ELEMENTS: PFNA-II BLADEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - NAIL HEAD ELEMENTS: HIP SCREWOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - NAIL HEAD ELEMENTS: PFNA-II BLADEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - NAILS: PFNA-IIOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNK - CONSTRUCTS: TFNOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
10MM/125 DEG TI CANN TFNA 360MM/RIGHT - STERILEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
LONG NAIL KIT R1.5, TI, LEFT GAMMA3? ?10X260MM X 125?STRYKER TRAUMA KIEL2020-03-27
TFNA FENESTRATED HELICAL BLADE 100MM - STERILEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-27
HELICAL BLADE/SCREW EXTRACTORWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-27
NAIL EXTRACTORWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-27
FITBONEWITTENSTEIN INTENS GMBH2020-03-27
FITBONEWITTENSTEIN INTENS GMBH2020-03-27
FITBONEWITTENSTEIN INTENS GMBH2020-03-27
FITBONEWITTENSTEIN INTENS GMBH2020-03-27
FITBONEWITTENSTEIN INTENS GMBH2020-03-27
FITBONEWITTENSTEIN INTENS GMBH2020-03-27

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