FDA.report

Black Diamond Pedicle Screw System

Primary DI
B06210012035
Brand
Black Diamond Pedicle Screw System
Company
Osseus Fusion Systems, LLC
Model
1001-2035
Catalog number
1001-2035
Device description
ROD, STRAIGHT, PERC, 5.5x35mm, 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

Related Records

Contact Domains

Product Codes

CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B06210012035PrimaryHIBCC0

GMDN Terms

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

TypeValueUnit
Length35Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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B06224200045Black Diamond POCT2420-00452420-00452023-06-14
B06224200050Black Diamond POCT2420-00502420-00502023-06-14
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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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