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AccuPlan System

FDA UDI

Class II (US FDA UDI)

by Medcad

Identity

Trade Name
AccuPlan System FDA UDI
Generic Name
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Device Name
ORTHOPEDIC, SURGICAL GUIDE, FIBULA FDA UDI
Model / Reference
ZB-K041 FDA UDI
Description
ORTHOPEDIC, SURGICAL GUIDE, FIBULA FDA UDI

Identifiers

Catalog Number
ZB-K041 FDA UDI
Primary DI / UDI-DI
00810007632063 FDA UDI
510(k) Number
K223421 FDA UDI
FDA Product Code
PBF FDA UDI
LLZ FDA UDI
GMDN Term
Custom-made organ/bone anatomy model/surgical guide kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
892.2050 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made organ/bone anatomy model/surgical guide kit

AccuPlan System by Medcad — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made organ/bone anatomy model/surgical guide kit.

Cleared under the same submission

K223421 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medcad

Sources (1)

  • FDA UDI 4c822329-34fb-4b80-be78-a4cc098a4b10 36 fields · synced Jun 8, 2026