FDA.reportPublic FDA data

Dark Star Deformity

Primary DI
B0751002570
Brand
Dark Star Deformity
Company
Republic Spine, LLC
Model
100257
Catalog number
DS0027
Device description
Straight Sounder
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
B0751002570PrimaryHIBCC0

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
561-334-2421james@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
B0751000490Dark Star Deformity100049DS00252025-11-18
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-08-02
00763000992026MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-08-02
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-07-30
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationMNH2026-07-28
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07290115932508Tower Guide STPREMIA SPINE LTDMNI2026-07-23
07290115932508Tower Guide STPREMIA SPINE LTDMNH2026-07-23
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
M719GL2290TiLockGenesys Orthopedics Systems LLCMNI2026-07-14
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
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