Home GUDID B062100100000J Black Diamond Pedicle Screw System
Primary DI B062100100000J
Brand Black Diamond Pedicle Screw System
Company Osseus Fusion Systems, LLC
Model 1001-0000
Catalog number 1001-0000 to 1010-9999
Device description The Osseus Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods and cross links. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
Published 2017-02-14
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 MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 71341402JV Direct Marking HIBCC 0 B062100100000J 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.
Device Sizes# Type, Value, Unit table Type Value Unit Depth 30 Millimeter Depth 35 Millimeter Depth 50 Millimeter Depth 70 Millimeter Depth 90 Millimeter Length 30 Millimeter Length 35 Millimeter Length 40 Millimeter Length 45 Millimeter Length 50 Millimeter Length 55 Millimeter Length 60 Millimeter Length 65 Millimeter Length 70 Millimeter Length 75 Millimeter Length 80 Millimeter Length 85 Millimeter Length 90 Millimeter Length 95 Millimeter Length 100 Millimeter Length 105 Millimeter Length 110 Millimeter Length 115 Millimeter Length 120 Millimeter Length 200 Millimeter Length 250 Millimeter Length 300 Millimeter Outer Diameter 4.5 Millimeter Outer Diameter 5.5 Millimeter Outer Diameter 6.5 Millimeter Outer Diameter 7.5 Millimeter Outer Diameter 8.5 Millimeter
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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