Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032830

FEI Number

3004167986

Entity Name

ORTHOPEDIC SCIENCES, INC

City/State/Country

Overland Park, KS, US

Establishment Address

6600 College Blvd Ste 138, Overland Park, KS 66211, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ORTHOPEDIC SCIENCES, INC. (Owner Number: 9051896)

Owner / Operator Contact Address

6600 College Blvd, SUITE 138, Overland Park, KS 66211, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K022139

PMA Number

N/A

All Registered 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 Custom-Hip Tool 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 CUSTOM HIP TOOL TITANIUM HIP TOOL S-BONE HIP TOOL TSY SHOULDER PLATE IMPLANT 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 S-Bone Hip Tool 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 Shoulder Plate Implant Titanium Hip Tool Locking Plate Q System Arthroscope Threaded Guide Wire Blunt Guide Wire Safety PX TITANIUM HIP TOOL TITANIUM HIP TOOL Hip Tool Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2014-04-04
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	2012-11-06
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2010-12-08
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-11-06
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-11-06
PPR	Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures	Orthopedic	Class 2	888.1100	2017-06-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
HWK	Trephine	Orthopedic	Class 1	888.4540	2003-08-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-11
HWA	Impactor	Orthopedic	Class 1	888.4540	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-11
GFF	Bur, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4820	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2015-12-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2007-10-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2014-07-18
HXI	Passer, Wire, Orthopedic	Orthopedic	Class 1	888.4540	2012-11-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2003-08-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-11-05

Official Correspondent

JAMES BRANNON, M.D.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ORTHOPEDIC SCIENCES, 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
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12

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-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

Similar Registrations

Registration Number	Establishment Name	Location
3013843055	BEIJING AK MEDICAL CO, LTD	Changping District Beijing, CN
3022777867	FIXIER S.A. DE C.V.	Doctor Mora Guanajuato, MX
3017209758	NEBULA SURGICAL PRIVATE LIMITED	Rajkot Gujarat, IN
3017609305	PRIMEMED INC.	Sungnam-city Gyeonggi, KR
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032830. Last updated year: 2026. Please use registration number 2032830 when referencing this establishment in official correspondence.