AccessGUDID - DEVICE: OZARK Cervical Plate System (10888857361652)

GUDID

Device Identifier (DI) Information

Brand Name: OZARK Cervical Plate System
Version or Model: 8801-45F95
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8801-45F95
Company Name: K2M, INC.

Primary DI Number: 10888857361652
Issuing Agency: GS1
Commercial Distribution End Date: April 23, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 146060863 *Terms of Use

Device Description: Plate, 5 Level, Size 95 mm

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
Length: 95 Millimeter

Device Record Status

Public Device Record Key: c996ce0e-f004-4085-a4d4-9a6ca71f9ff2
Public Version Date: November 20, 2025
Public Version Number: 8
DI Record Publish Date: October 12, 2017