ORTHONOVIS, INC.

FDA Device Registration & Listing · Palm Coast, FL, US · Registration 3015946784

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015946784
FEI Number
3015946784
Entity Name
ORTHONOVIS, INC.
City/State/Country
Palm Coast, FL, US
Establishment Address
1 Hargrove Grade Ste 4, Palm Coast, FL 32137, US
Establishment Type(s)
Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
OrthoNovis, Inc. (Owner Number: 10061543)
Owner / Operator Contact Address
1 Hargrove Grade, 2F, Palm Coast, FL 32137, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K130613
PMA Number
N/A

All Registered Proprietary Names

BPSS Affinity Wrist Fracture System IONz IntraHeal Trochanteric Fixation System CSM NoviCoid AC Joint Repair System BPSS Foot Plating System OrthoNovis Bone Plate and Screw System BPS Wrist Fracture System BTB Bone Graft Putty BPSS Memory Metal Staple System OrthoNovis BPSS Cannulated Screws

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-27
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2023-04-27
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2023-04-27
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-27
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-04-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-27
KGN Wound Dressing With Animal-Derived Material(S) Unknown Class U N/A 2026-03-25
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2025-12-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-04-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-28
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-10-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-28
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-03-25
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2023-04-27
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-10-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-28
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-10-28

Official Correspondent

Ken West

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OrthoNovis, Inc.
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
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM 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 3015946784. Last updated year: 2026. Please use registration number 3015946784 when referencing this establishment in official correspondence.
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