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Innovasis® Cranial System

FDA UDI

Class II (US FDA UDI)

by Innovasis, Inc.

Identity

Trade Name
Innovasis® Cranial System FDA UDI
Generic Name
Cranioplasty plate, alterable FDA UDI
Device Name
CP Ti FDA UDI
Model / Reference
C2BR16226 FDA UDI
Description
CP Ti FDA UDI

Identifiers

Catalog Number
C2BR16226 FDA UDI
Primary DI / UDI-DI
M711C2BR162260 FDA UDI
510(k) Number
K141644 FDA UDI
FDA Product Code
GWO FDA UDI
GXR FDA UDI
HBW FDA UDI
GMDN Term
Cranioplasty plate, alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5320 FDA UDI
882.5250 FDA UDI
882.5360 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cranioplasty plate, alterable

Innovasis® Cranial System by Innovasis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, alterable.

Cleared under the same submission

K141644 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Innovasis, Inc.

Sources (1)

  • FDA UDI 47225b85-bd86-4314-a126-d507003667a8 37 fields · synced May 30, 2026