Paragon Medical Device (Changzhou) Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 53 device types.
Paragon Medical Device (Changzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Tamp, Clamp and 51 other device types. Its earliest product listing with the FDA dates from 1994.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007539489 |
| FEI number | 3007539489 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer |
Chinese Registration
| Chinese legal name | 派瑞格医疗器械（常州）有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | 3A GDH Industrial Park |
| Postal code | 213033 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | Trauma Tray, TL-HEX, Empty, Galaxy Wrist Tray Empty | 2011 | 17 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | Class 2 | Truelok Trauma – Instruments Case, US, Truelok Trauma Case, US | 2015 | 6 |
| Appliance, Fixation, Spinal Interlaminal | Class 2 | TAP RBT071675 RG Cortical 7.5 AWL-TIP Long, TAP RBT071655 RG Cortical 5.5 AWL-TIP Long, Cortical TAP, Dual Lead, NAVIGATED-?4.5MM, TAP RBT071565 RG Cortical 6.5 AWL-TIP Short, Cortical TAP, Dual Lead, NAVIGATED-?6.5MM, TAP RBT071545 RG Cortical 4.5 AWL-TIP Short and 10 more | 2021 | 11 |
| Appliance, Fixation, Spinal Intervertebral Body | Class 2 | TAP RBT071675 RG Cortical 7.5 AWL-TIP Long, TAP RBT071655 RG Cortical 5.5 AWL-TIP Long, Cortical TAP, Dual Lead, NAVIGATED-?4.5MM, TAP RBT071565 RG Cortical 6.5 AWL-TIP Short, Cortical TAP, Dual Lead, NAVIGATED-?6.5MM, TAP RBT071545 RG Cortical 4.5 AWL-TIP Short and 10 more | 2021 | 14 |
| Bit, Drill | Class 1 | Zimmer Biomet, Universal Pin, Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit), Fluted Pin | 2013 | 27 |
| Broach | Class 1 | 2013 | 12 | |
| Clamp | Class 1 | Tornier HRS Max | 2013 | 24 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Class 2 | 4.2MM Drill BIT, Medium, 4.2MM Drill BIT, Long, 3.5MM Drill BIT, Medium, 3.5MM Drill BIT, Short, 3MM Drill BIT, Short, 3MM Drill BIT, Long and 19 more | 2021 | 3 |
| Driver, Prosthesis | Class 1 | Driver | 2013 | 9 |
| Elevator | Class 1 | 3MM Drill BIT, Medium | 2026 | 5 |
| Guide, Surgical, Instrument | Class 1 | Ambi, Zimmer Biomet | 2013 | 26 |
| Impactor | Class 1 | Zimmer Biomet | 2013 | 18 |
| Instrument, Cutting, Orthopedic | Class 1 | 2017 | 11 | |
| Instrument, Manual, Surgical, General Use | Class 1 | 2008 | 110 | |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | Class 1 | Peri-LOC, IMN™ Instruments, Drill Bit, AO | 2015 | 23 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | Class 1 | 2022 | 10 | |
| Intervertebral Fusion Device With Bone Graft, Lumbar | Class 2 | Driver 9735253 T-Handle 5mm Hex | 2018 | 14 |
| Mallet | Class 1 | Mallet | 2017 | 6 |
| Neurological Stereotaxic Instrument | Class 2 | Cranial Reducing Tube | 2016 | 5 |
| Orthopedic Manual Surgical Instrument | Class 1 | Drill Sleeve Insert, Orthopedic Manual Surgical Instrument, 3MM Drill BIT, Long, LITe Funnel, Bone Tap, Freehand Drill IMN Instruments ø3.5x185mm and 54 more | 2007 | 53 |
| Orthopedic Stereotaxic Instrument | Class 2 | TAP RBT071675 RG Cortical 7.5 AWL-TIP Long, TAP RBT071655 RG Cortical 5.5 AWL-TIP Long, Cortical TAP, Dual Lead, NAVIGATED-?4.5MM, TAP RBT071565 RG Cortical 6.5 AWL-TIP Short, Cortical TAP, Dual Lead, NAVIGATED-?6.5MM, TAP RBT071545 RG Cortical 4.5 AWL-TIP Short and 32 more | 2017 | 5 |
| Pin, Fixation, Smooth | Class 2 | Sterilization BOX Empty | 2017 | 12 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | Class 2 | Quad Plate Plus Caddy Empty, Eight Plate Plus Caddy Empty, Extended Plus Line Caddy Empty, Sterilization BOX Empty | 2018 | 2 |
| Plate, Fixation, Bone | Class 2 | 2017 | 22 | |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class 2 | Initia Intermediate Size Broach Case | 2016 | 14 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | Legion | 2013 | 3 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Class 2 | Legion | 2013 | 7 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Class 2 | Legion | 2013 | 6 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | Legion | 2013 | 10 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | Class 2 | Legion | 2013 | 7 |
| Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | Legion | 2013 | 3 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | Class 2 | 2015 | 5 | |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class 2 | Persona Revision Knee System, Zimmer Persona Personalized Knee System, Persona® The Personalized Knee System, Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Legion | 2013 | 12 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Class 2 | Persona Revision Knee System, Zimmer Persona Personalized Knee System, Persona® The Personalized Knee System, Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2018 | 8 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class 2 | Persona Revision Knee System, Persona® The Personalized Knee System PERSONA NATURAL TIBIA BASEPLATES, Zimmer Persona Personalized Knee System, Persona® The Personalized Knee System, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Legion | 2013 | 21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing | Class 3 | 2016 | 4 | |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | Class 2 | 2017 | 8 | |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | Class 2 | 2017 | 6 | |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | Class 2 | 2017 | 9 | |
| Punch, Femoral Neck | Class 1 | 2015 | 4 | |
| Punch, Surgical | Class 1 | 2016 | 9 | |
| Pusher, Socket | Class 1 | 2017 | 6 | |
| Retractor | Class 1 | 2013 | 34 | |
| Rod, Fixation, Intramedullary And Accessories | Class 2 | Ankle Hindfoot Nailing System – Extraction Instruments Case Empty, Ankle Hindfoot Nailing System – Insertion Instruments Case Empty, Ankle Hindfoot Nailing System – Drills AND Reamers Case Empty, Chimaera Instrument Tray, Empty, Extraction Instrument Tray Empty, Chimaera Instrument Tray Extra Empty and 2 more | 2015 | 17 |
| Screwdriver | Class 1 | Legion, Screwdriver | 2013 | 18 |
| Software For Diagnosis/Treatment | Class 2 | Trauma Tray, TL-HEX, Empty | 2018 | 3 |
| Tamp | Class 1 | 2013 | 7 | |
| Tap, Bone | Class 1 | Intermediate, Zimmer Biomet, Tap, Locking, AO | 2013 | 12 |
| Template | Class 1 | Keel TIB Punch Guide SZ1.5-4, Tornier HRS Max | 2013 | 21 |
| Thoracolumbosacral Pedicle Screw System | Class 2 | TAP RBT071675 RG Cortical 7.5 AWL-TIP Long, TAP RBT071655 RG Cortical 5.5 AWL-TIP Long, Cortical TAP, Dual Lead, NAVIGATED-?4.5MM, TAP RBT071565 RG Cortical 6.5 AWL-TIP Short, Cortical TAP, Dual Lead, NAVIGATED-?6.5MM, TAP RBT071545 RG Cortical 4.5 AWL-TIP Short and 10 more | 2021 | 15 |
| Tray, Surgical | Class 1 | 2013 | 36 | |
| Tray, Surgical, Instrument | Class 1 | Triathlon Pro CS Insert Trials Tray (Size 0-7), Triathlon Primary & MIS Patella Preparation Tray, TS Universal Baseplate Finishing Tray, Universal Lid, Triathlon Pro Miscellaneous Instruments Caddy, Femoral Posterior Augment Trials (Size 1-8) Caddy and 54 more | 1994 | 105 |
| Wrench | Class 1 | 2016 | 14 |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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