Model: PK627315
DI: 00810188324542
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-14
Current Version: 2026-05-22
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:
350f4943-c9d0-40e9-afeb-adc5e26e5ede
Distribution Status:
In Commercial Distribution
DUNS Number:
962301359
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810188324542
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58908
Name: Custom-made cranial bone prosthesis
Definition:
An implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.
FDA Product Codes
GXN
Plate, Cranioplasty, Preformed, Non-Alterable
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Premarket Submissions
Item #1 - Submission Number:
K161052
Item #1 - Supplement Number:
000
Item #2 - Submission Number:
K180064
Item #2 - Supplement Number:
000