Model: SD980.065
Catalog: SD980.065
DI: 05420060351648
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Titanium 3D Printed Guide for Frontal Bone, Type 2
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:
55f430f2-5afa-40ad-8b15-b060bcb9f96f
Distribution Status:
In Commercial Distribution
DUNS Number:
373139427
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05420060351648
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60826
Name: Custom-made orthopaedic/craniofacial surgical guide
Definition:
A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is made of synthetic polymer materials and is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.
FDA Product Codes
PPT
Cranial Surgical Planning And Instrument Guides
Premarket Submissions
Submission Number:
K253308
Supplement Number:
000