FDA.reportPublic FDA data

OrthoPediatrics Locking Cannulated Blade Plate System

Primary DI
00841132198513
Brand
OrthoPediatrics Locking Cannulated Blade Plate System
Company
ORTHOPEDIATRICS CORP.
Model
00-1200-2001-S
Catalog number
00-1200-2001-S
Device description
90 Deg Locking Cannulated Infant Blade 30mm x 5mm x 2 Hole
Published
2026-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260323000OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.2026-04-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132198513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132198513008411321985138411321985130841132198513

GMDN Terms#

Term, Definition table
TermDefinition
Femoral fixation plate/bladeAn 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.

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379xxx@xxx.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840536822543Prone Perfect03-1300-880103-1300-88012026-05-22
00840536822550Prone Perfect03-1300-880203-1300-88022026-05-22
00840536822567Prone Perfect03-1300-880303-1300-88032026-05-22
00840536822574Prone Perfect03-1300-880403-1300-88042026-05-22
00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
00840536822598Prone Perfect03-1300-880603-1300-88062026-05-22
00840536822604Prone Perfect03-1300-880703-1300-88072026-05-22
00840536822611Prone Perfect03-1300-880803-1300-88082026-05-22
00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
00840536822635Prone Perfect03-1300-881003-1300-88102026-05-22
00840536822642Prone Perfect03-1300-881103-1300-88112026-05-22
00841132199244OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6000-S00-1200-6000-S2026-05-13
00841132199251OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6001-S00-1200-6001-S2026-05-13
00841132199268OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6002-S00-1200-6002-S2026-05-13
00841132199275OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6003-S00-1200-6003-S2026-05-13
00841132199282OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6004-S00-1200-6004-S2026-05-13
00841132199299OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6005-S00-1200-6005-S2026-05-13
00841132199305OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6006-S00-1200-6006-S2026-05-13
00841132199312OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6014-S00-1200-6014-S2026-05-13
00841132199329OrthoPediatrics Locking Cannulated Blade Plate System00-1200-6015-S00-1200-6015-S2026-05-13

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Primary DI, Brand, Company table
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