PARAGON 28

FDA Device Registration & Listing · Englewood, CO, US · Registration 3008650117

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
3008650117
FEI Number
3008650117
Entity Name
PARAGON 28
City/State/Country
Englewood, CO, US
Establishment Address
14445 Grasslands Dr., Englewood, CO 80112, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Paragon 28 (Owner Number: 10033376)
Owner / Operator Contact Address
14445 Grasslands Dr., Englewood, CO 80112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K981386
PMA Number
N/A

All Registered Proprietary Names

Rongeur Additive Orthopaedics Patient Specific 3D Locking Lattice Screws Additive Orthopaedics Patient Specific 3D Locking Lattice Plates axIOLink PCFD Tether System R3ACT Stabilization System Impactor Bone Hook Phantom Metatarsal Shortening System Gorilla SMO Plating System Rasp HammerTube System Monkey Rings External Fixation System Precision MIS Bunion System Grappler Suture Anchor System TenoTac Soft Tissue Fixation System TenoTac 2 Soft Tissue Fixation System PROMO Triplanar Hallux Valgus Correction System Gorilla Plating System Gorilla HEvans Plate Baby Gorilla Plating System BOW & ARROW Plates Baby Gorilla/Gorilla Plating System Gorilla R3CON Plating System Gorilla TUFFNEK Screw System R3LEASE Stabilization System Monkey Rings External Fixation System Paratrooper Plantar Plate Repair System Passer K-Wire Olive Wire Guide Wire Osteotome FJ-2000 Driver Baby Gorilla/Gorilla Plating System Bone Marrow Harvest Needle Forceps Patient Specific Marking Guides Monkey Bars™ Pin to Bar External Fixation System Tamp BEAST Demineralized Bone Matrix BEAST PLUS BEAST Injectable Putty Mgnum Bone Void Filler (BVF) Mixing and Delivery System Titan 3-D Wedge System Mgnum Bone Void Filler (BVF) Grappler Suture Anchor Extraosseous Crosswire System Grappler Suture Anchor R3INFORCE System Gorilla Ankle Fracture Plating System SILVERBACK Plating System Paragon 28 Custom Made Devices San Gio™ Baby Bennetts Additive Orthopaedics Locking Lattice Plate Additive Orthopaedics Locking Lattice Screw Drill bit BEAST Injectable Putty Grappler Interference Screw System Template JAWS Nitinol Staple System Extractor Joust Beaming Screw System Monster Screw System Monster BITE Screw System PRECISION Jones Fracture System Precision MIS Bunion System Reamer Monster Screw System Phantom® Fibula Nail System Additive Orthopaedics Bone Wedge System MAVEN PSI MAVEN Patient-Specific Instrumentation System Compressor Distractor Gorilla Central Column Fusion Plating System Depth Gauge Surgical instrument cleaning brush/tool APEX 3D Total Ankle Replacement System The Brachiator Mini External Fixation System Curette Additive Orthopaedics Hammertoe Correction System Blunt Needle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTX Rongeur Orthopedic Class 1 888.4540 2019-08-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-07-08
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2026-04-22
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-04-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-04-18
HWA Impactor Orthopedic Class 1 888.4540 2020-11-18
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 2018-12-13
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2023-07-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-07-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-07-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-07-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-07-12
HTR Rasp General, Plastic Surgery Class 1 878.4800 2018-12-13
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2019-06-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2023-10-18
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2026-01-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-12-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-03
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2019-06-03
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-06-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2022-01-17
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2020-04-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-04-09
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2019-01-18
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2018-12-13
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2015-04-20
HAB Saw, Powered, And Accessories General, Plastic Surgery Class 1 878.4820 2024-05-02
HXX Screwdriver Orthopedic Class 1 888.4540 2019-08-21
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-07-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-07-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-07-05
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2019-08-21
HTD Forceps General, Plastic Surgery Class 1 878.4800 2019-02-21
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2022-07-07
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-11-13
HXG Tamp Orthopedic Class 1 888.4540 2013-04-28
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2021-09-01
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-09-01
FMF Syringe, Piston General Hospital Class 2 880.5860 2021-10-26
PLF Bone Wedge Orthopedic Class 2 888.3030 2017-07-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-07-26
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-10-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-07-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2021-02-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-02-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-02-16
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2026-04-10
GAD Retractor General, Plastic Surgery Class 1 878.4800 2019-08-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-07-08
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-04-28
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2026-05-12
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-05-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-08-15
HWT Template Orthopedic Class 1 888.4800 2019-08-21
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2017-07-26
HWB Extractor Orthopedic Class 1 888.4540 2019-08-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-06-03
HTO Reamer Orthopedic Class 1 888.4540 2013-04-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-29
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2018-01-29
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2024-09-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-09-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-07-08
OYK Ankle Arthroplasty Implantation System Orthopedic Class 2 888.3110 2021-02-16
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-02-16
HWN Instrument, Compression Orthopedic Class 1 888.4540 2013-05-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-07-06
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-07-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-07-06
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2019-08-21
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-08-21
HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3110 2021-05-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-12-11
HTF Curette General, Plastic Surgery Class 1 878.4800 2018-12-13
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-07-08
FPA Set, Administration, Intravascular General Hospital Class 2 880.5440 2025-11-17

Official Correspondent

Tina O'Brien

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Paragon 28
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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008650117. Last updated year: 2026. Please use registration number 3008650117 when referencing this establishment in official correspondence.
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