FDA.reportPublic FDA data

Dark Star Deformity

Primary DI
B0751000490
Brand
Dark Star Deformity
Company
Republic Spine, LLC
Model
100049
Catalog number
DS0025
Device description
Republic Spine Small, Curved Probe (Lenke)
Published
2025-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
B0751000490PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-855-0704james@rspine.com

Regulatory Flags#

DUNS number
061891717
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B075102001400Dark Star Navigation102001-40DSN-40T2026-05-14
B07511002428S0606T0Restore Lumbar Interbody Fusion System110024-28S0606TRETL-28S0606T2026-01-14
B07511002428S0706T0Restore Lumbar Interbody Fusion System110024-28S0706TRETL-28S0706T2026-01-14
B07511002428S0806T0Restore Lumbar Interbody Fusion System110024-28S0806TRETL-28S0806T2026-01-14
B07511002428S0906T0Restore Lumbar Interbody Fusion System110024-28S0906TRETL-28S0906T2026-01-14
B07511002428S1006T0Restore Lumbar Interbody Fusion System110024-28S1006TRETL-28S1006T2026-01-14
B07511002428S1106T0Restore Lumbar Interbody Fusion System110024-28S1106TRETL-28S1106T2026-01-14
B07511002428S1206T0Restore Lumbar Interbody Fusion System110024-28S1206TRETL-28S1206T2026-01-14
B07511002428S1306T0Restore Lumbar Interbody Fusion System110024-28S1306TRETL-28S1306T2026-01-14
B07511002428S1406T0Restore Lumbar Interbody Fusion System110024-28S1406TRETL-28S1406T2026-01-14
B07511002428S1506T0Restore Lumbar Interbody Fusion System110024-28S1506TRETL-28S1506T2026-01-14
B07510000875700Dark Star Deformity100008-7570DSDA-75702025-11-18
B0751000530Dark Star Deformity100053DS00262025-11-18
B075100054L0Dark Star Deformity100054-01DT004T-L2025-11-18
B0751001300Dark Star Deformity100130DS00342025-11-18
B0751001370Dark Star Deformity100137DS00392025-11-18
B075100187010Dark Star Deformity100187-01DS0001-C2025-11-18
B075100187020Dark Star Deformity100187-02DS0001-CL2025-11-18
B0751001970Dark Star Deformity100197DS00372025-11-18
B0751002060Dark Star Deformity100206DS00042025-11-18

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