AccessGUDID - DEVICE: Dark Star Deformity (B07510000565300)

GUDID

Device Identifier (DI) Information

Brand Name: Dark Star Deformity
Version or Model: 100005-6530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DSDAR-6530
Company Name: Republic Spine, LLC

Primary DI Number: B07510000565300
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 061891717 *Terms of Use

Device Description: Alpha Reduction Pedicle Screw - Ø 6.5 mm x 30 mm

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWP	Appliance, Fixation, Spinal Interlaminal
NKB	Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 30 Millimeter
Device Size Text, specify: 6.5mm diameter

Device Record Status

Public Device Record Key: 32989ded-a46d-4492-a181-94069c9d1d0c
Public Version Date: March 21, 2025
Public Version Number: 6
DI Record Publish Date: August 31, 2016