FDA.reportPublic FDA data

Black Diamond Pedicle Screw System

Primary DI
B06210038555
Brand
Black Diamond Pedicle Screw System
Company
Osseus Fusion Systems, LLC
Model
1003-8555
Catalog number
1003-8555
Device description
SCREW, REDTN PED, NON-CANN, 8.5x55mm, BLK DIAMOND
Published
2017-10-09
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
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B06210038555PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Outer Diameter0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
B06234500010Pisces-SC Standalone Cervical Interbody3450-00103450-00102026-10-29
B06234500020Pisces-SC Standalone Cervical Interbody3450-00203450-00202026-10-29
B06234500030Pisces-SC Standalone Cervical Interbody3450-00303450-00302026-10-29
B06234500040Pisces-SC Standalone Cervical Interbody3450-00403450-00402026-10-29
B06234500050Pisces-SC Standalone Cervical Interbody3450-00503450-00502026-10-29
B06234500052Pisces-SC Standalone Cervical Interbody3450-00523450-00522026-10-29
B06234500053Pisces-SC Standalone Cervical Interbody3450-00533450-00532026-10-29
B06234500054Pisces-SC Standalone Cervical Interbody3450-00543450-00542026-10-29
B06234500061Pisces-SC Standalone Cervical Interbody3450-00613450-00612026-10-29
B06234500062Pisces-SC Standalone Cervical Interbody3450-00623450-00622026-10-29
B06234500063Pisces-SC Standalone Cervical Interbody3450-00633450-00632026-10-29
B06234500064Pisces-SC Standalone Cervical Interbody3450-00643450-00642026-10-29
B06234500070Pisces-SC Standalone Cervical Interbody3450-00703450-00702026-10-29
B06234500071Pisces-SC Standalone Cervical Interbody3450-00713450-00712026-10-29
B06234500080Pisces-SC Standalone Cervical Interbody3450-00803450-00802026-10-29
B06234500081Pisces-SC Standalone Cervical Interbody3450-00813450-00812026-10-29
B06234500090Pisces-SC Standalone Cervical Interbody3450-00903450-00902026-10-29
B06234500100Pisces-SC Standalone Cervical Interbody3450-01003450-01002026-10-29
B06234500110Pisces-SC Standalone Cervical Interbody3450-01103450-01102026-10-29
B06234500121Pisces-SC Standalone Cervical Interbody3450-01213450-01212026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B06210018530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018530Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018535Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018535Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018540Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018540Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018545Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018545Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018550Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018550Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018555Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018555Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018560Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018560Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018565Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018565Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018570Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018570Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018575Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018575Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018580Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018580Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018585Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018585Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B06210018590Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-10-09
B06210018590Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-10-09
B062100100000JBlack Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-02-14
B062100100000JBlack Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-02-14
B06210022070Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNI2017-01-13
B06210022070Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLCMNH2017-01-13