FDA.reportPublic FDA data

Dark Star Deformity

Primary DI
B075100005751000
Brand
Dark Star Deformity
Company
REPUBLIC SPINE
Model
100005-75100
Catalog number
DSDAR-75100
Device description
Alpha Reduction Pedicle Screw - Ø 7.5 mm x 100 mm
Published
2024-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B075100005751000PrimaryHIBCC0

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
Length100Millimeter
Outer Diameter7.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
561-334-2421james@rspine.com

Regulatory Flags#

DUNS number
061891717
Device count
1
DM exempt
true
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
B0751000200450Dark Star Deformity100020-045DS-20452024-05-22
B0751000200550Dark Star Deformity100020-055DS-20552024-05-22
B0751000200650Dark Star Deformity100020-065DS-20652024-05-22
B0751000200750Dark Star Deformity100020-075DS-20752024-05-22
B0751000200850Dark Star Deformity100020-085DS-20852024-05-22
B0751000800550Dark Star Deformity100080-055DS-10552024-05-22
B0751000800650Dark Star Deformity100080-065DS-10652024-05-22
B0751000800750Dark Star Deformity100080-075DS-10752024-05-22
B075100005651000Dark Star Deformity100005-65100DSDAR-651002024-05-07
B07510000565600Dark Star Deformity100005-6560DSDAR-65602024-05-07
B07510000565700Dark Star Deformity100005-6570DSDAR-65702024-05-07
B07510000565900Dark Star Deformity100005-6590DSDAR-65902024-05-07
B075100005751100Dark Star Deformity100005-75110DSDAR-751102024-05-07
B07510000575600Dark Star Deformity100005-7560DSDAR-75602024-05-07
B07510000575700Dark Star Deformity100005-7570DSDAR-75702024-05-07
B07510000575800Dark Star Deformity100005-7580DSDAR-75802024-05-07
B07510000575900Dark Star Deformity100005-7590DSDAR-75902024-05-07
B075100005851000Dark Star Deformity100005-85100DSDAR-851002024-05-07
B075100005851100Dark Star Deformity100005-85110DSDAR-851102024-05-07
B07510000585700Dark Star Deformity100005-8570DSDAR-85702024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536216710neon3Ulrich GmbH & Co. KGKWP2026-05-26
00763000817305VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
00763000817312VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-03-16
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03662663097505LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097512LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097529LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097536LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097543LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097550LineSiderHighridge Medical, LLCKWP2025-10-03
03662663097567LineSiderHighridge Medical, LLCKWP2025-10-03