CHESAPEAKE® Stabilization System

Basic Information

• Brand Name: CHESAPEAKE® Stabilization System
• Primary DI: 10888857082007
• Version / Model: 3608-212133
• Catalog Number: 3608-212133
• Company Name: K2M, INC.
• Labeler DUNS: 146060863
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-10
• Public Version: 2
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: d0bb585e-c2d9-4071-89c7-f9a23b05387f

Device Description

3-Screw Titanium Implant, Size 13x18x12 mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OVE	Intervertebral fusion device with integrated fixation, cervical	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34170	Vertebral body prosthesis	An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888857082007	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111439	000

Device Sizes

Type	Value	Unit	Text
Width	18	Millimeter
Device Size Text, specify			3 Screw
Height	12	Millimeter
Length	13	Millimeter