Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006460162

FEI Number

3006460162

Entity Name

ORTHOPEDIATRICS, CORP

City/State/Country

Warsaw, IN, US

Establishment Address

2850 Frontier Dr, Warsaw, IN 46582, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ORTHOPEDIATRICS, CORP (Owner Number: 9102640)

Owner / Operator Contact Address

2850 Frontier Drive, --, Warsaw, IN 46582, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PediFlex Flexible Nail System Drill bit Trephine Hex driver Easy out Periosteal Elevator Response Navigation Instruments Response BandLoc Spinal Fixation Orthex External Fixation System (Point and Click Software) H-Plate PediPlate O-Plate I-Plate Wrench INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Response 5.5/6 Spine System Aspire Ortho Spine System PediFrag Percutaneous Pinning Set PediLoc Fragment System General Instruments Orthex External Fixation System Stylet General Instruments OrthoPediatrics PediNail Intramedullary Platform Template Pediatric Nailing Platform Tibia OrthoPediatrics ACL Reconstruction System General Instruments Guide wire General Instruments General Instruments General Instruments OrthoPediatrics® Locking Cannulated Blade Plate System 3, 3.5, 7 Bone Screws OrthoPediatrics Bone Screws SCFE Screw Bone Screw System Cortical, Cancellous and Cannulated Bone Screws 4 Bone Screws PediScrew General Instruments OrthoPediatrics Wrist Fusion Plate Tendon Passer HOOK, BONE Pediatric Plating Platform Hip SCREWDRIVER Instrument, Bending or Contouring General instruments General Instruments Orthex RESPONSE Rib and Pelvic System General Instruments Drive Rail System Orthex Half Pin Ultima Half Pin General Instruments Ultima HA Coated Half Pins and Wire OrthoPediatrics PediFlex Flexible Nail System Pedi-Flex Nail Response BandLoc Spinal Fixation Response 5.5/6 Spine System Response 4.5/5 Spine System General Instruments PediLoc Pedi-Loc PediLoc Locking Plate System Pediatric Plating Platform Small-Mini PediNail Intramedullary Platform Rasp Awl General Instruments Drive Rail System Mallet Vilex EZ-Fix VerteGlide Spinal Growth Guidance System Dynamic Femur Fracture (DF2) Brace; PediHip Rigid Brace ; PediHip Modular Abduction Harness OrthoPediatrics Blade Plate System Locking Cannulated Blade Plate System Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur Instrument, Compression File PediFlex and Interlocking Clamp General Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-06-26
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2019-08-26
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2026-06-08
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2021-02-18
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2020-04-06
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2023-02-13
OSN	Software For Diagnosis/Treatment	Orthopedic	Class 2	888.3030	2023-02-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-05-07
OBT	Plate, Bone, Growth Control, Pediatric, Epiphysiodesis	Orthopedic	Class 2	888.3030	2009-05-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-05-07
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-03-28
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-09-07
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2015-05-26
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-05-26
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2015-05-26
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2015-05-26
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2015-05-26
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-01-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2015-01-13
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2015-01-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-01-13
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2016-09-28
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2025-03-14
OSN	Software For Diagnosis/Treatment	Orthopedic	Class 2	888.3030	2025-03-14
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2025-03-14
GAH	Stylet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-08-26
HTO	Reamer	Orthopedic	Class 1	888.4540	2016-09-28
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2018-05-14
HWT	Template	Orthopedic	Class 1	888.4800	2023-09-07
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-09-08
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2013-10-21
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2017-01-20
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2019-08-26
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2017-01-20
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2017-01-20
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-01-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-05-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-05-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2008-12-02
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2016-09-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-28
HWQ	Passer	Orthopedic	Class 1	888.4540	2019-10-21
KIK	Hook, Bone	General, Plastic Surgery	Class 1	878.4800	2019-04-17
JDO	Device, Fixation, Proximal Femoral, Implant	Orthopedic	Class 2	888.3030	2025-05-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-05-06
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2020-01-22
HXP	Instrument, Bending Or Contouring	Orthopedic	Class 1	888.4540	2019-10-21
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	2016-09-28
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-09-28
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-12-13
OSN	Software For Diagnosis/Treatment	Orthopedic	Class 2	888.3030	2019-12-13
MDI	Prosthesis, Rib Replacement	Orthopedic	Class 2	888.3070	2024-01-22
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2017-01-20
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2022-04-12
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2022-04-12
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2019-12-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-28
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-01-20
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2019-12-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2008-07-11
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2016-08-12
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-11-28
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-11-28
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2017-01-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2009-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-01-30
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-12-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-12-12
HWA	Impactor	Orthopedic	Class 1	888.4540	2023-05-03
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2022-11-07
HWJ	Awl	Orthopedic	Class 1	888.4540	2019-03-28
HWB	Extractor	Orthopedic	Class 1	888.4540	2017-01-20
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-13
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2022-01-13
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2019-03-28
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-12-13
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2019-12-13
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-03-18
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2025-03-18
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2023-04-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2011-11-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2011-11-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2025-04-25
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2019-10-21
HTP	File	Orthopedic	Class 1	888.4540	2026-05-22
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2021-02-18
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2017-01-20

Official Correspondent

Ray Garrison

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHOPEDIATRICS, CORP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K895079	Buckman Co., Inc.	ACE BEADED K-WIRES ACE OLIVE WIRES	1989-09-13
K922193	Osteo AG	OSTEO KIRSCHNER WIRE	1992-07-23
K850026	Kirkstil Corp., Inc.	ORTHOPEDIC IMPLANT NAILS & PINS	1985-05-20
K963367	Rms Div.	RMS K-WIRE	1996-10-30
K260601	Blue Belt Technologies, Inc.	REAL INTELLIGENCE CORI	2026-03-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-05	Biomet, Inc.	2	Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006460162. Last updated year: 2026. Please use registration number 3006460162 when referencing this establishment in official correspondence.