AccessGUDID - DEVICE: MESA® Small Stature Spinal System (10888857389014)

GUDID

Device Identifier (DI) Information

Brand Name: MESA® Small Stature Spinal System
Version or Model: 3001-80807H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3001-80807H
Company Name: K2M, INC.

Primary DI Number: 10888857389014
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146060863 *Terms of Use

Device Description: Offset Laminar Hook, Right Size 7 mm X 8 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?
65115	Bone-screw internal spinal fixation system hook	An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design 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)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Thoracolumbosacral pedicle screw system
OSH	Pedicle screw spinal system, adolescent idiopathic scoliosis
MNH	Orthosis, spondylolisthesis spinal fixation
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
KWQ	Appliance, fixation, spinal intervertebral body
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL

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: 8 Millimeter
Device Size Text, specify: Right
Width: 7 Millimeter
Outer Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: 5cfd0980-2477-4559-b57b-3b4d39724968
Public Version Date: June 28, 2024
Public Version Number: 5
DI Record Publish Date: December 06, 2017