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Bespa Charcot System

FDA UDI

Class II (US FDA UDI)

by Kapstone Manufacturing

Identity

Trade Name
Bespa Charcot System FDA UDI
Generic Name
Intermedullary nail screw-alignment receiver FDA UDI
Device Name
Segmental Column Guide Frame FDA UDI
Model / Reference
BSP01-6-1501-01 FDA UDI
Description
Segmental Column Guide Frame FDA UDI

Identifiers

Catalog Number
BSP01-6-1501-01 FDA UDI
Primary DI / UDI-DI
00810041320285 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Intermedullary nail screw-alignment receiver FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Intermedullary nail screw-alignment receiver

Bespa Charcot System by Kapstone Manufacturing — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intermedullary nail screw-alignment receiver.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kapstone Manufacturing

Sources (1)

  • FDA UDI e76b1ff7-03f9-4808-a474-e4c4094723bd 34 fields · synced May 31, 2026