AccessGUDID - DEVICE: ASTRA Spine System (M824A5TC331)

GUDID

Device Identifier (DI) Information

Brand Name: ASTRA Spine System
Version or Model: A5T-C33
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SPINECRAFT, LLC

Primary DI Number: M824A5TC331
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: Tandem, Closed, fitting 5.5 and 6mm, 33mm

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?
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNH	Orthosis, spondylolisthesis spinal fixation
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION

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
No Device Sizes

Device Record Status

Public Device Record Key: a9f28eda-140e-4ec0-b81e-31fc4559be50
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: September 11, 2015