DEVICE: PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (06903195108596)
Device Identifier (DI) Information
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
KT-T5L14H2
In Commercial Distribution
CF26050015
Kontour(Xi'An) Medical Technology Co.,Ltd.
KT-T5L14H2
In Commercial Distribution
CF26050015
Kontour(Xi'An) Medical Technology Co.,Ltd.
No description.
Device Characteristics
| MR Safe | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 46268 | Cranioplasty plate, non-alterable |
An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
|
Active | true |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
802630c2-87b6-4cc7-93a1-20531e887a78
June 09, 2025
2
December 08, 2022
June 09, 2025
2
December 08, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined