AccessGUDID - DEVICE: ASTRA-OCT Spine System (M824A3OS50141)

GUDID

Device Identifier (DI) Information

Brand Name: ASTRA-OCT Spine System
Version or Model: A3OS-5014
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A3OS-5014
Company Name: SPINECRAFT, LLC

Primary DI Number: M824A3OS50141
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 Dia. 5.0mm Occipital Bone Screw, 14mm

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?
66947	Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.	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: ec11979d-1890-492d-a753-1e22a78368d8
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: October 03, 2018