AccessGUDID - DEVICE: Zuma-L™ (10889981059934)

GUDID

Device Identifier (DI) Information

Brand Name: Zuma-L™
Version or Model: 95-6043
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 95-6043
Company Name: SEASPINE ORTHOPEDICS CORPORATION

Primary DI Number: 10889981059934
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Height Trial, 45 mm x 14 mm, 8°

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?
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; 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). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
OVD	Intervertebral fusion device with integrated fixation, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082926	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
Device Size Text, specify: Height Trial, 45 mm x 14 mm, 8°

Device Record Status

Public Device Record Key: 19dc3dfa-bb80-49da-a6dc-237591c50717
Public Version Date: September 18, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2015