CHESAPEAKE® Stabilization System

FDA UDI

Class II (US FDA UDI)

by K2m, Inc.

Identity

Trade Name: CHESAPEAKE® Stabilization System FDA UDI
Generic Name: Vertebral body prosthesis FDA UDI
Device Name: Offset PEEK & Titanium Implant, Size 12x17x9 mm, 7 Deg. FDA UDI
Model / Reference: 3613-20912F FDA UDI
Description: Offset PEEK & Titanium Implant, Size 12x17x9 mm, 7 Deg. FDA UDI

Identifiers

Catalog Number: 3613-20912F FDA UDI
Primary DI / UDI-DI: 10888857083554 FDA UDI
510(k) Number: K133494 FDA UDI
FDA Product Code: OVE FDA UDI
OVD FDA UDI
GMDN Term: Vertebral body prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 17 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI
Height — 9 Millimeter FDA UDI
Angle — 7 degree FDA UDI

Category: Vertebral body prosthesis

CHESAPEAKE® Stabilization System by K2m, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vertebral body prosthesis.

FORTIFY — GLOBUS MEDICAL, INC. · Class II
VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Novel — ALPHATEC SPINE, INC. · Class II
Regatta — SeaSpine Orthopedics Corporation · Class II
C-THRU™ Anterior Spinal System — BIOMET SPINE LLC · Class II
VERTE-STACK® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Novel — ALPHATEC SPINE, INC. · Class II
XPAND-R — GLOBUS MEDICAL, INC. · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: K2m, Inc.

Sources (1)

FDA UDI 759bfb42-8c66-448c-aaeb-39b8813bcd1d 37 fields · synced Jun 1, 2026