← Back to catalogue

AccuShape® Titanium Patient-Specific Implant

FDA UDI

Class II (US FDA UDI)

by Medcad

Identity

Trade Name
AccuShape® Titanium Patient-Specific Implant FDA UDI
Generic Name
Cranioplasty plate, non-alterable FDA UDI
Device Name
Titanium Cranial Implant, Large FDA UDI
Model / Reference
MC-AST30 FDA UDI
Description
Titanium Cranial Implant, Large FDA UDI

Identifiers

Catalog Number
MC-AST30 FDA UDI
Primary DI / UDI-DI
00810007631059 FDA UDI
510(k) Number
K220357 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
MRI Safety
MR Unsafe FDA UDI

Category: Cranioplasty plate, non-alterable

AccuShape® Titanium Patient-Specific Implant 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

K220357 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medcad

Sources (1)

  • FDA UDI edc32e48-2d03-48ff-9243-d30406872f53 36 fields · synced Jun 6, 2026