FDA.reportPublic FDA data

Pediatric Nailing Platform Femur

Primary DI
00840194405461
Brand
Pediatric Nailing Platform Femur
Company
ORTHOPEDIATRICS CORP.
Model
01-1501-0061
Catalog number
01-1501-0061
Device description
Reamer Extension
Published
2022-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840194405461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840194405461008401944054618401944054610840194405461

GMDN Terms#

Term, Definition table
TermDefinition
Screw-extraction orthopaedic reamer, reusableA surgical tool designed for overdrilling, gripping, and extracting an implanted surgical screw shaft when the screw head has become defective or detached, or the shaft has broken. It is in the form of a thin hollow metal shaft, with saw teeth at the cutting edge and a conical thread within the lumen. The device is rotated around the screw shaft to remove a thin layer of bone, either by a surgical power tool or a manual handle, until the internal thread grips the screw for removal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840194405980Pediatric Nailing Platform Femur01-1501-052001-1501-05202022-09-16
00840194405997Pediatric Nailing Platform Femur01-1503-005501-1503-00552022-09-16
00840194406000Pediatric Nailing Platform Femur01-1503-005601-1503-00562022-09-16
00840194407687Pediatric Nailing Platform Femur01-1501-010201-1501-01022022-09-16
00840194407700Pediatric Nailing Platform Femur01-1503-005701-1503-00572022-09-16
00840194407717Pediatric Nailing Platform Femur01-1503-005801-1503-00582022-09-16
00840194407724Pediatric Nailing Platform Femur01-1503-005901-1503-00592022-09-16
00840194407748Pediatric Nailing Platform Femur01-1501-052101-1501-05212022-09-16
00840194417280Pediatric Nailing Platform Femur01-1501-015001-1501-01502022-09-16
00840194417297Pediatric Nailing Platform Femur01-1501-015101-1501-01512022-09-16
00840194417303Pediatric Nailing Platform Femur01-1501-015201-1501-01522022-09-16
00840194417310Pediatric Nailing Platform Femur01-1501-052201-1501-05222022-09-16
00840194417327Pediatric Nailing Platform Femur01-1501-052301-1501-05232022-09-16
00840194417334Pediatric Nailing Platform Femur01-1501-052401-1501-05242022-09-16
00840194445986Pediatric Nailing Platform | Tibia01-1510-005001-1510-00502023-09-15
00840194445993Pediatric Nailing Platform | Tibia01-1510-005101-1510-00512023-09-15
00840194462587Pediatric Nailing Platform | Tibia01-1540-000001-1540-00002023-09-15
00840194462594Pediatric Nailing Platform | Tibia01-1540-000101-1540-00012023-09-15
00840194462686Pediatric Nailing Platform | Tibia01-1510-006001-1510-00602023-09-15
00840194462693Pediatric Nailing Platform | Tibia01-1510-006101-1510-00612023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337120674Inner Drill Reamer 4.0 mm, cannulatedJoimax GmbHHTO2026-10-28
04250337120681Outer Drill, bluntJoimax GmbHHTO2026-10-28
04250337120698Outer Drill, crownJoimax GmbHHTO2026-10-28
04250337120810Inner Drill Reamer 4,0 mm, kanülliert, reusableJoimax GmbHHTO2026-10-28
00889024702264OsseoFitZimmer, Inc.HTO2026-10-27
00889024702271OsseoFitZimmer, Inc.HTO2026-10-27
00889024702318OsseoFitZimmer, Inc.HTO2026-10-27
00889024702325OsseoFitZimmer, Inc.HTO2026-10-27
00889024702332OsseoFitZimmer, Inc.HTO2026-10-27
00889024702349OsseoFitZimmer, Inc.HTO2026-10-27
04250337114086Crown Reamer red, fine, reusableJoimax GmbHHTO2026-10-27
04250337119609Crown Reamer red, fine, reusableJoimax GmbHHTO2026-10-27
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592290TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592306TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592313TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592320TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23