Device
PEEK Customized Skull Implant, X-LARGE
Manufacturer
KELYNIAM GLOBAL, INC.
Model: PEEK-IM1004 Catalog: PEEK-IM1004 DI: 00810125929434 Status: New MRI: MR Safe Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08 Distribution End: 2026-04-30
Description
PEEK Customized Skull Implant, X-LARGE CSI012226-MK1
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: fa8b670c-9b33-4da2-89b9-9df9ecbebfa7
Distribution Status: Not in Commercial Distribution
DUNS Number: 785088829
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: Yes
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00810125929434
Type: Primary
Issuing Agency: GS1
GMDN
Code: 46267
Name: Cranioplasty plate, alterable
Definition:
An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can 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.
FDA Product Codes
GWO
Plate, Cranioplasty, Preformed, Alterable
Premarket Submissions
Submission Number: K182711
Supplement Number: 000