Home GUDID B06217205135 Pisces-SA
Primary DI B06217205135
Brand Pisces-SA
Company Osseus Fusion Systems, LLC
Model 1720-5135
Catalog number 1720-5135
Device description Bone Screw, Variable, Self-Drilling, 35mm, PISCES-SA
Published 2022-05-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B06217205135 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 933442068 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B06224200000 Black Diamond POCT 2420-0000 2420-0000 2023-06-14 B06224200001 Black Diamond POCT 2420-0001 2420-0001 2023-06-14 B06224200002 Black Diamond POCT 2420-0002 2420-0002 2023-06-14 B06211000524 Aries-TS TSLIF Lumbar Interbody System 1100-0524S 1100-0524S 2022-11-07 B06211000525 Aries-TS TSLIF Lumbar Interbody System 1100-0525S 1100-0525S 2022-11-07 B06211000526 Aries-TS TSLIF Lumbar Interbody System 1100-0526S 1100-0526S 2022-11-07 B06211000527 Aries-TS TSLIF Lumbar Interbody System 1100-0527S 1100-0527S 2022-11-07 B06211000528 Aries-TS TSLIF Lumbar Interbody System 1100-0528S 1100-0528S 2022-11-07 B06211000529 Aries-TS TSLIF Lumbar Interbody System 1100-0529S 1100-0529S 2022-11-07 B06211000126 Aries-TS TSLIF Lumbar Interbody System 1100-0126S 1100-0126S 2022-11-04 B06211000127 Aries-TS TSLIF Lumbar Interbody System 1100-0127S 1100-0127S 2022-11-04 B06211000128 Aries-TS TSLIF Lumbar Interbody System 1100-0128S 1100-0128S 2022-11-04 B06211000129 Aries-TS TSLIF Lumbar Interbody System 1100-0129S 1100-0129S 2022-11-04 B06211000326 Aries-TS TSLIF Lumbar Interbody System 1100-0326S 1100-0326S 2022-11-04 B06211000327 Aries-TS TSLIF Lumbar Interbody System 1100-0327S 1100-0327S 2022-11-04 B06211000328 Aries-TS TSLIF Lumbar Interbody System 1100-0328S 1100-0328S 2022-11-04 B06211000329 Aries-TS TSLIF Lumbar Interbody System 1100-0329S 1100-0329S 2022-11-04 B06211000520 Aries-TS TSLIF Lumbar Interbody System 1100-0520S 1100-0520S 2022-11-04 B06211000521 Aries-TS TSLIF Lumbar Interbody System 1100-0521S 1100-0521S 2022-11-04 B06211000522 Aries-TS TSLIF Lumbar Interbody System 1100-0522S 1100-0522S 2022-11-04
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