Identity
- Trade Name
- Innovasis® Cranial System FDA UDI
- Generic Name
- Cranioplasty plate screw FDA UDI
- Device Name
- Ti 6Al 4V (ELI) FDA UDI
- Model / Reference
- C5SD16003 FDA UDI
- Description
- Ti 6Al 4V (ELI) FDA UDI
Identifiers
- Catalog Number
- C5SD16003 FDA UDI
- Primary DI / UDI-DI
- M711C5SD160030 FDA UDI
- 510(k) Number
- K141644 FDA UDI
- FDA Product Code
- GWO FDA UDIGXR FDA UDIHBW FDA UDI
- GMDN Term
- Cranioplasty plate screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5320 FDA UDI882.5250 FDA UDI882.5360 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Millimeter FDA UDIOuter Diameter — 1.6 Millimeter FDA UDI
Category: Cranioplasty plate screw
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 screw.
- Neuro Plating System — OSTEONIC CO., Ltd. · Class II
- STERILE TRAC SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Neuro Plating System — OSTEONIC CO., Ltd. · Class II
- Neuro Plating System — OSTEONIC CO., Ltd. · Class II
- Neuro Plating System — OSTEONIC CO., Ltd. · Class II
- Neuro Plating System — OSTEONIC CO., Ltd. · Class II
- Neuro Plating System — OSTEONIC CO., Ltd. · Class II
- Neuro Plating System — OSTEONIC CO., Ltd. · Class II
Cleared under the same submission
K141644 also covers:
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
- Innovasis® Cranial System — Innovasis, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Innovasis, Inc.
Sources (1)
- FDA UDI 1546f031-9c8c-445a-83e3-2984e10c6a0a 37 fields · synced May 30, 2026