FDA.report

OrthoPediatrics PediFoot Deformity Correction System

Primary DI
00841132159293
Brand
OrthoPediatrics PediFoot Deformity Correction System
Company
ORTHOPEDIATRICS CORP.
Model
01-1007-0027
Catalog number
01-1007-0027
Device description
Variable angle drill guide, 2.5mm
Published
2019-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZXGuide, surgical, instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841132159293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132159293008411321592938411321592930841132159293

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(574)268-6379jjaskula@orthopediatrics.com

Regulatory Flags

DUNS number
796416191
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840536822581Prone Perfect03-1300-880503-1300-88052026-05-22
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00840536822628Prone Perfect03-1300-880903-1300-88092026-05-22
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00840194498975Response 5.5/6.001-1300-935001-1300-93502026-03-03
00840194498982Response 5.5/6.001-1300-936001-1300-93602026-03-03
00840536800244Response 5.5/6.001-1300-913501-1300-91352026-03-03
00840536800251Response 5.5/6.001-1300-913601-1300-91362026-03-03
00840194499194Contracture ManagementNS-6000-3001NS-6000-30012026-03-02
00840194499200Contracture ManagementNS-6000-3002NS-6000-30022026-03-02
00840194499217Contracture ManagementNS-6000-3003NS-6000-30032026-03-02
00840194499224Contracture ManagementNS-6000-3004NS-6000-30042026-03-02
00840194499231Contracture ManagementNS-6000-3005NS-6000-30052026-03-02

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09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
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