AccessGUDID - DEVICE: Anteralign Spinal System with Titan nanoLock Surface technology (00763000147402)

GUDID

Device Identifier (DI) Information

Brand Name: Anteralign Spinal System with Titan nanoLock Surface technology
Version or Model: 46821612
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00763000147402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: TRIAL 46821612 MD 6DG 32X25X12MM

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":	No
For Single-Use:	No
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?
44788	Spinal implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLO	Orthopedic stereotaxic instrument
HWT	TEMPLATE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214010	000
K221180	000
K222383	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: d15c214d-c396-4c6c-bb75-a0f38d435b10
Public Version Date: October 28, 2022
Public Version Number: 4
DI Record Publish Date: May 06, 2022