FDA.report

Dark Star

Primary DI
B0751002760
Brand
Dark Star
Company
REPUBLIC SPINE
Model
1
Catalog number
DS0015L
Device description
In-situ rod bender left
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B0751002760PrimaryHIBCC0

GMDN Terms

TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. 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

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B0751000200650Dark Star Deformity100020-065DS-20652024-05-22
B0751000200750Dark Star Deformity100020-075DS-20752024-05-22
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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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