Home GUDID EMAHPSS11175301 Polyaxial screw,w/o cannulation 7.5/30mm
Primary DI EMAHPSS11175301
Brand Polyaxial screw,w/o cannulation 7.5/30mm
Company mahe medical gmbh
Model PSS11-17530
Catalog number PSS11-17530
Device description Polyaxial screw,w/o cannulation 7.5/30mm
Published 2016-07-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EMAHPSS11175301 Package HIBCC 1 In Commercial Distribution EMAHPSS11175300 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Regulatory Flags# DUNS number 342243334 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published EMAHKM714590 Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unit KM71-459 KM71-459 2016-06-13 EMAHKM715100 Steinmann pin w. trocar/round end 2.0mm/229mm, 6 pcs./unit KM71-510 KM71-510 2016-04-28 EMAHKM715130 Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unit KM71-513 KM71-513 2016-04-28 EMAHKM718800 Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer KM71-880 KM71-880 2016-06-10 04050659210974 mahe medical GmbH 004-80009 2019-11-05 04050659484832 mahe medical GmbH KM71-459 2019-11-05 04050659484948 mahe medical GmbH KM71-510 2019-11-05 04050659484955 mahe medical GmbH KM71-513 2019-11-05 04050659485228 mahe medical GmbH KM71-675 2019-11-05 04050659485600 mahe medical GmbH KM71-880 2019-11-05 EMAHCHM01100 Set screw w.plate f.polyaxial screws CHM01-10 CHM01-10 2016-07-05 EMAHCHM01110 Set screw f.polyaxial screws CHM01-11 CHM01-11 2016-07-05 EMAHPSR1175450 Polyaxial screw reduct., w/o cannulation 7.5mm/45mm PSR11-7545 PSR11-7545 2016-08-04 EMAHPSR1175500 Polyaxial screw reduct., w/o cannulation 7.5mm/50mm PSR11-7550 PSR11-7550 2016-08-04 EMAHPSR1175550 Polyaxial screw reduct., w/o cannulation 7.5mm/55mm PSR11-7555 PSR11-7555 2016-08-04 EMAHPSR1175600 Polyaxial screw reduct., w/o cannulation 7.5mm/60mm PSR11-7560 PSR11-7560 2016-08-04 EMAHPSS0845250 Polyaxial screw, w/o cannulation, 4.5mm/25mm PSS08-4525 PSS08-4525 2016-07-05 EMAHPSS0845300 Polyaxial screw, w/o cannulation, 4.5mm/30mm PSS08-4530 PSS08-4530 2016-07-06 EMAHPSS0845350 Polyaxial screw, w/o cannulation, 4.5mm/35mm PSS08-4535 PSS08-4535 2016-07-06 EMAHPSS0845400 Polyaxial screw, w/o cannulation, 4.5mm/40mm PSS08-4540 PSS08-4540 2016-07-06
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