AccessGUDID - DEVICE: ASTRA-OCT Spine System (M824A3ST151)

GUDID

Device Identifier (DI) Information

Brand Name: ASTRA-OCT Spine System
Version or Model: A3S-T15
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A3S-T15
Company Name: SPINECRAFT, LLC

Primary DI Number: M824A3ST151
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: ASTRA-OCT T15 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, threaded, implantable, non-bioabsorbable disc intended to be threaded into the 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
NKG	Orthosis, cervical pedicle screw spinal fixation
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181350	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: b2f80b9f-c4e8-4822-a362-310d9d82c818
Public Version Date: September 11, 2024
Public Version Number: 4
DI Record Publish Date: October 03, 2018