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CASPIAN Spinal System

FDA UDI

Class I (US FDA UDI)

by K2m, Inc.

Identity

Trade Name
CASPIAN Spinal System FDA UDI
Generic Name
Internal spinal fixation procedure kit, single-use FDA UDI
Device Name
Fixed Drill Bit Size Ø2.8x16 mm FDA UDI
Model / Reference
1101-90135 FDA UDI
Description
Fixed Drill Bit Size Ø2.8x16 mm FDA UDI

Identifiers

Catalog Number
1101-90135 FDA UDI
Primary DI / UDI-DI
10888857017276 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

Yes

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

Category: Internal spinal fixation procedure kit, single-use

CASPIAN Spinal 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 e00248e4-3b69-4900-99ed-668357c8f774 35 fields · synced May 30, 2026