Device
110° Cannulated Hybrid Blade Plate 45mm x 5mm X 3 Hole
Manufacturer
ORTHOPEDIATRICS CORP.
ORTHOPEDIATRICS CORP.
Model: 00-1200-3206-S
Catalog: 00-1200-3206-S
DI: 00841132186947
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
110° Cannulated Hybrid Blade Plate 45mm x 5mm X 3 Hole
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cc219b76-d519-4186-a951-f874289a280b
Distribution Status:
In Commercial Distribution
DUNS Number:
796416191
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00841132186947
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66943
Name: Femoral fixation plate/blade
Definition:
An implantable, non-customized sheet of firm material that incorporates a blade at one end designed to be attached with screws to the proximal and/or distal femur to treat a fracture; the blade is intended to be introduced into the bone to assist with fixation. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available is various blade angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate/blade.
FDA Product Codes
HRS
Plate, fixation, bone
Premarket Submissions
Submission Number:
K260323
Supplement Number:
000