FDA Registration
Active
🇺🇸 United States
ORTHOPEDIC SCIENCES, INC
Reg #: 2032830
·
FEI: 3004167986
·
Expires 2026
Products
21
Proprietary Names
119
Establishment Types
3
Classifications
21
Registration Details
- Registration Name
- ORTHOPEDIC SCIENCES, INC
- Registration Number
- 2032830
- FEI Number
- 3004167986
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6600 College Blvd Ste 138
- City
- Overland Park
- State
- KS
- ZIP
- 66211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K040850
Owner / Operator
- Firm Name
- ORTHOPEDIC SCIENCES, INC.
- Operator Number
- 9051896
- Address
- 6600 College Blvd, SUITE 138
- City
- Overland Park
- State
- KS
- Postal Code
- 66211
- Country
- US
- Correspondent
- JAMES K BRANNON, M.D.
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2003-08-27 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2014-04-04 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2012-11-06 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2012-11-06 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2012-11-06 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2010-12-08 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2012-11-06 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2012-11-06 |
| Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures | PPR | Class 2 | Orthopedic | No | 2017-06-06 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2003-08-27 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2012-11-06 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2012-11-06 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2015-12-29 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2012-11-06 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2009-11-05 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2009-11-05 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2024-08-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-11-16 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2012-11-06 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2012-11-06 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2012-11-06 |
Proprietary Names
CUSTOM HIP TOOL
TITANIUM HIP TOOL
S-BONE HIP TOOL
TSY SHOULDER PLATE IMPLANT
The Piranha 4.5FR 180
The Piranha 3.5FR
The Piranha 4.5FC 132
Q Arthroscopy System Shavers with Piranha Technology
Q Arthroscope System Shavers
The Piranha 4.5AG 180
The Piranha 4.5FR 132
The Piranha 4.5AG 132
The Piranha 3.5FC
The Piranha 4.5FC 180
The Piranha 3.5AG
Arthro Select Tubing
ArthoSelect Tubing AST-700
S-Bone Hip Tool
The Subchondral Sleeve
The Drum Burr
Q Arthroscopy System Burrs
The Targeting Guide
2.3 mm Blunt Wire
The Pusher
3.2 mm Blunt Wire
Custom-Hip Tool
Q Arthroscope Spine
T Hex Driver Cannulated
T Hex Driver Non-Cannulated
Hex Driver
Restricted Hexagonal Driver
Nitinol Wire NW-001
Irrigation Osteoplasty Needle IN-004
Introducer Needle IN-002
Introducer Cannula IC-135
The Harpy
Introducer Cannula IC-120
Introducer Cannula IC-155
The Clear Cannula
The Q Port
Slotted Cannula
Teardrop
Introducer Cannula IC-145
Endoscopic Portal
Flat Drop
Endoscopic Trephine, Multiple Products
OT-A Curette
HPS Bone Tool Vacuum Assisted Bone and Marrow Harvesting System
My Shoulder Components and Accessories
The Bone Shuttle
Bone Tool Harvest Augmentation Curette, Multiple Sizes
My Hip Endoscopic Core Decompression
The Beacon Biomass Harvester
OT-A Outologous Trephine-Aspirator
CR-170 Long Bone Coring Trephine
Bone Coring Trephine, Multiple Sizes
My Knee Components and Accessories
Multiple Products
TS-Bone Hip Tool
Impactor
Titanium Shoulder Plate Implant
The Hawk
The Vulture X
The Eagle X
The Naked Burr Multiple Sizes
Q Arthroscopy System Burrs of Prey
The Hawk S
The Vulture
The Eagle
The Harrier S
The Talon
The Falcon
The Harrier X
The Vulture EX
The Harrier SRX
The Falcon X
The Harrier
The Harrier EX
The Harrier SX
Biomass Delivery Curette
System Egret Outflow Adapter and Accessories
Biomass Delivery Trephine
The Angler 4.5L
The Angler 3.5
The Red Belly 4.5S
The Red Belly 4.5L
The Angler 4.5S
The Red Belly 3.5
Titanium Hip Tool Locking Plate
Q System Arthroscope
Threaded Guide Wire
Blunt Guide Wire
Safety PX
TITANIUM HIP TOOL
Hip Tool Implant
Outologous Spinal Fixation System
OXLFIX ACL Interference Screw
Knee Articulochondral Osteoplasty Instrument Tray
Hip Tool Retrieval Tray
Titanium TSY Shoulder Plate Instrument Case
The Beacon Endoscopic Pedicle Screw Guidance System
HPS Bone Tool Instrument Tray
Outologous Spinal Fixation System Instrumentation Tray
Titanium Hip Tool Bone Graft Stabilization System
The AO Procedure
Q System Hip Arthroscopy Instrumentation Tray
OT-A Instrument Tray
Q System Arthroscopes and Light Cables
THE EUROPA DRILL BIT
Drill Bit
Drill Bit Multiple Products
Bone Saver PL
Osteoinductive Reservoir OIR Bone and Marrow Collection System
Bone Saver
Dual Spike Endoscopic Tubing and Drainage Bag DT-300
Standard Dual Spike Endoscopic Tubing with Trumpet Valve and Drainage Bag
The Biomass Filter Element Standard
The Biomass Filter Element Large
Arthro Select Tubing and Accessories
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198