AccessGUDID - DEVICE: APEX Spine System (M824SS6T20F1)

GUDID

Device Identifier (DI) Information

Brand Name: APEX Spine System
Version or Model: SS6-T20F
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SS6-T20F
Company Name: SPINECRAFT, LLC

Primary DI Number: M824SS6T20F1
Issuing Agency: HIBCC
Commercial Distribution End Date: September 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 783908713 *Terms of Use

Device Description: T20 drive M6 Set Screw

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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?
65553	Spinal bone set screw	A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, spondylolisthesis spinal fixation
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
KWQ	Appliance, fixation, spinal intervertebral body
NKB	Thoracolumbosacral pedicle screw system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062513	000
K092825	000
K102488	000
K110906	000
K132603	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 9c325069-f815-4f4a-9e54-c7c53062f3c0
Public Version Date: July 14, 2025
Public Version Number: 7
DI Record Publish Date: December 03, 2017