DEVICE: OrthoPediatrics Locking Cannulated Blade Plate System (00840194417907)

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Device Record History
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Device Identifier (DI) Information
OrthoPediatrics Locking Cannulated Blade Plate System
00-1200-1500
In Commercial Distribution
00-1200-1500
ORTHOPEDIATRICS CORP.
00840194417907
GS1

1
796416191 *Terms of Use
90° Cannulated Hybrid Blade Plate 15mm x 5mm X 3 Hole
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Device Characteristics
MR Conditional
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
66943 Femoral fixation plate/blade
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
HRS Plate, fixation, bone
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K260323 000
No CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
0ec2f97d-cb52-4bef-b9c7-da9cad540a5a
May 20, 2026
1
May 12, 2026
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(574)268-6379
xxx@xxx.com
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