FDA.reportPublic FDA data

PediLoc Locking Plate System

Primary DI
00841132115367
Brand
PediLoc Locking Plate System
Company
ORTHOPEDIATRICS CORP.
Model
00-1050-4022
Catalog number
00-1050-4022
Device description
4.0MM NON LOCKING CANCELLOUS FULLY THREADED SCREW SIZE 22MM
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K083286000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083286000ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEMOrthoPediatrics Corp.2009-01-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132115367PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132115367008411321153678411321153670841132115367

GMDN Terms#

Term, Definition table
TermDefinition
Growth-correction orthopaedic fixation plate kitA collection of implantable devices used to redirect the angle of growth of long bones in paediatric patients where the growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow). It typically includes various-sized sheets of surgical steel or titanium alloy, and bone screws to attach the sheets to the bone surface over the growth plates. The screws may be allowed to swivel in their position so that the implant acts like a hinge, permitting growth at the growth plate to gradually straighten the limb.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796416191
Device count
1
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841132133200PediFlex01-1000-00101-1000-0012017-02-15
00841132133217PediFlex01-1000-00201-1000-0022017-02-15
00841132135280PediNail21-1500-00721-1500-0072017-02-15
00841132135297PediNail21-1500-01021-1500-0102017-02-15
00841132135303PediNail21-1500-01221-1500-0122017-02-15
00841132135310PediNail21-1500-01321-1500-0132017-02-15
00841132135334PediNail21-1500-01921-1500-0192017-02-15
00841132135341PediNail21-1500-11221-1500-1122017-02-15
00841132135358PediNail21-1500-11921-1500-1192017-02-15
00841132135372PediNail21-1500-911321-1500-91132017-02-15
00841132135389PediNail21-1500-921321-1500-92132017-02-15
00841132135396PediNail21-1500-921421-1500-92142017-02-15
00841132179833Vilex ToolP460-45-100P460-45-1002020-03-02
00841132179888Orthex ToolPP460-15-110PP460-15-1102020-03-02
00841132142325eZ-Fix500-G500-G2020-02-28
00841132142905eZ-Fix900-CW-14900-CW-142020-02-28
00841132142950eZ-Fix900-TW-30900-TW-302020-02-28
00841132143025eZ-Fix925-TW-30925-TW-302020-02-28
00841132125014General Instrument01-1003-300101-1003-30012016-09-25
00841132125021General Instrument01-1003-300201-1003-30022016-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08904255300071ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300125ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300149ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
08904255300156ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300231ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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08904255300743ARMAR™ / ARTIS™MERIL HEALTHCARE PRIVATE LIMITEDHRS2026-07-18
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