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AccuShape®

FDA UDI

Class II (US FDA UDI)

by Medcad

Identity

Trade Name
AccuShape® FDA UDI
Generic Name
Cranioplasty plate, non-alterable FDA UDI
Device Name
PEEK Cranial Implant, Medium FDA UDI
Model / Reference
ACS-002 FDA UDI
Description
PEEK Cranial Implant, Medium FDA UDI

Identifiers

Catalog Number
ACS-002 FDA UDI
Primary DI / UDI-DI
00810007630014 FDA UDI
510(k) Number
K110684 FDA UDI
FDA Product Code
GXN FDA UDI
GMDN Term
Cranioplasty plate, non-alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Cranioplasty plate, non-alterable

AccuShape® by Medcad — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, non-alterable.

Cleared under the same submission

K110684 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 0f7363d7-73e0-4d05-9da4-4bfc3e455970 36 fields · synced Jun 8, 2026