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CAYMAN Plate System

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
CAYMAN Plate System FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
Drill Size Ø3.5x65 mm FDA UDI
Model / Reference
1208-90002 FDA UDI
Description
Drill Size Ø3.5x65 mm FDA UDI

Identifiers

Catalog Number
1208-90002 FDA UDI
Primary DI / UDI-DI
10888857019607 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 3.5 Millimeter FDA UDI
Length — 65 Millimeter FDA UDI

Category: Internal spinal fixation procedure kit, single-use

CAYMAN Plate System by K2m, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K2m, Inc.

Sources (1)

  • FDA UDI 2bbb8e95-f94d-4fd7-90c0-9e1c7777e31d 36 fields · synced Jun 8, 2026