AccessGUDID - DEVICE: 54mm ANTERIOR LUMBAR PLATE (00846468028824)

GUDID

Device Identifier (DI) Information

Brand Name: 54mm ANTERIOR LUMBAR PLATE
Version or Model: 25-LP-54
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 25-LP-54
Company Name: Pioneer Surgical Technology, Inc.

Primary DI Number: 00846468028824
Issuing Agency: GS1
Commercial Distribution End Date: May 22, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 793384496 *Terms of Use

Device Description: 54mm ANTERIOR LUMBAR PLATE

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:	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?
46653	Spinal fixation plate, non-bioabsorbable	A small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

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: baba33a9-97b5-4198-b6dd-44d227d924ef
Public Version Date: November 20, 2025
Public Version Number: 7
DI Record Publish Date: November 23, 2015