Model: ANC1329
Catalog: ANC1329
DI: 03700569658304
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
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:
880ce639-2d77-4191-a9b8-197e48ea07e2
Distribution Status:
In Commercial Distribution
DUNS Number:
263281904
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
03700569658304
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 65079
Name: Osteotomy guide, single-use
Definition:
A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.
FDA Product Codes
PBF
Orthopaedic Surgical Planning And Instrument Guides
Premarket Submissions
Submission Number:
K240415
Supplement Number:
000