AccessGUDID - DEVICE: ASTRA-OCT Spine System (M824A3HAR451)

GUDID

Device Identifier (DI) Information

Brand Name: ASTRA-OCT Spine System
Version or Model: A3H-AR45
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A3H-AR45
Company Name: SPINECRAFT, LLC

Primary DI Number: M824A3HAR451
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 Angled Right Hook, 4.5mm

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?
65115	Bone-screw internal spinal fixation system hook	An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.	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: 16540602-4cdb-4ad3-b373-fc8b33e8ab56
Public Version Date: September 05, 2024
Public Version Number: 3
DI Record Publish Date: October 03, 2018