FDA.report

Dark Star

Primary DI
B07510000555350
Brand
Dark Star
Company
REPUBLIC SPINE
Model
1
Catalog number
DSR-5535
Device description
Reduction Screw
Published
2016-08-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B07510000555350PrimaryHIBCC0

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
Device Size Text, specify0
Length35Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
954-249-0817rusty@rspine.com
561-334-2421james@rspine.com

Regulatory Flags

DUNS number
061891717
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 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
B075100005751000Dark Star Deformity100005-75100DSDAR-751002024-05-07
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

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