FDA.report

Dark Star

Primary DI
B0751002680
Brand
Dark Star
Company
REPUBLIC SPINE
Model
1
Catalog number
DS0004
Device description
Set Screw Inserter
Published
2016-09-16
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
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B0751002680PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
9542490817rusty@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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
088000333582064CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2020-03-26
088000333846944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333851104CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333859984CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860184CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860494CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860564CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860634CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860704CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860874CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861004CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861314CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24