Model: Proximal Humerus Plate
Catalog: G02-R095
DI: G682G02R0951
Status: New
MRI: Labeling does not contain MRI Safety Information
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:
359c6bf2-9aa7-4430-9238-c364481bed11
Distribution Status:
In Commercial Distribution
DUNS Number:
071462633
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:
G682G02R0951
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 46647
Name: Orthopaedic fixation plate, non-bioabsorbable
Definition:
A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
FDA Product Codes
HRS
Plate, Fixation, Bone
HWC
Screw, Fixation, Bone
Premarket Submissions
Submission Number:
K241296
Supplement Number:
000