FDA.reportPublic FDA data

Black Diamond Pedicle Screw System

Primary DI
B06210012250
Brand
Black Diamond Pedicle Screw System
Company
Osseus Fusion Systems, LLC
Model
1001-2250
Catalog number
1001-2250
Device description
ROD, STRAIGHT, PERC, 5.5x250mm, BLK DIAMOND
Published
2017-01-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B06210012250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn 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
TypeValueUnit
Length250Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-330-5960Info@osseus.com

Regulatory Flags#

DUNS number
933442068
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B06224200000Black Diamond POCT2420-00002420-00002023-06-14
B06224200001Black Diamond POCT2420-00012420-00012023-06-14
B06224200002Black Diamond POCT2420-00022420-00022023-06-14
B06224200025Black Diamond POCT2420-00252420-00252023-06-14
B06224200030Black Diamond POCT2420-00302420-00302023-06-14
B06224200035Black Diamond POCT2420-00352420-00352023-06-14
B06224200040Black Diamond POCT2420-00402420-00402023-06-14
B06224200045Black Diamond POCT2420-00452420-00452023-06-14
B06224200050Black Diamond POCT2420-00502420-00502023-06-14
B06224200055Black Diamond POCT2420-00552420-00552023-06-14
B06224200060Black Diamond POCT2420-00602420-00602023-06-14
B06224200065Black Diamond POCT2420-00652420-00652023-06-14
B06224200070Black Diamond POCT2420-00702420-00702023-06-14
B06224200075Black Diamond POCT2420-00752420-00752023-06-14
B06224200080Black Diamond POCT2420-00802420-00802023-06-14
B06224200085Black Diamond POCT2420-00852420-00852023-06-14
B06224200090Black Diamond POCT2420-00902420-00902023-06-14
B06224200095Black Diamond POCT2420-00952420-00952023-06-14
B06224200100Black Diamond POCT2420-01002420-01002023-06-14
B06224200105Black Diamond POCT2420-01052420-01052023-06-14

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Primary DI, Brand, Company table
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00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
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