Data / Medical devices / United States / Orthopedic Sciences, Inc

Orthopedic Sciences, Inc: FDA-registered device maker in Overland Park, KS, United States, 12 510(k) clearances

Name: Orthopedic Sciences, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Orthopedic Sciences, Inc is registered with the FDA (registration 2032830) in Overland Park, KS, United States. It lists 21 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 3, 2016. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Orthopedic Sciences, Inc

FDA registration number: 2032830
FEI number: 3004167986
Address: 6600 College Blvd Ste 138, Overland Park, KS, United States, 66211
Owner or operator: ORTHOPEDIC SCIENCES, INC. (9051896)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: August 27, 2003
Registered through: 2026
Brand names listed: 2.3 mm Blunt Wire, 3.2 mm Blunt Wire, ArthoSelect Tubing AST-700, Arthro Select Tubing, Arthro Select Tubing and Accessories, Biomass Delivery Curette, Biomass Delivery Trephine, Blunt Guide Wire and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Arthroscopic	NBH	1	Specification developer	accessdata.fda.gov
Arthroscope	HRX	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Bit, Drill	HTW	1	Specification developer	accessdata.fda.gov
Blade, Saw, General & Plastic Surgery, Surgical	GFA	1	Specification developer	accessdata.fda.gov
Bur, Surgical, General & Plastic Surgery	GFF	1	Specification developer	accessdata.fda.gov
Burr, Orthopedic	HTT	1	Specification developer	accessdata.fda.gov
Catheter And Tip, Suction	JOL	2	Specification developer	accessdata.fda.gov
Curette	HTF	1	Specification developer	accessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft Tissue	MAI	2	Specification developer	accessdata.fda.gov
Guide, Needle, Surgical	GDF	1	Specification developer	accessdata.fda.gov
Impactor	HWA	1	Specification developer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Specification developer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Passer, Wire, Orthopedic	HXI	1	Specification developer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer, Specification developer	accessdata.fda.gov
Screwdriver	HXX	1	Specification developer	accessdata.fda.gov
Surgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures	PPR	2	Specification developer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Specification developer	accessdata.fda.gov
Trephine	HWK	1	Specification developer	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 3, 2016	K161174	Nanova Interference Screw	MAI	Substantially Equivalent	Nanova Biomaterials, Inc.	accessdata.fda.gov
February 26, 2014	K133018	OSI Q SYSTEM ARTHROSCOPES	HRX	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
August 26, 2009	K091398	ARTHROSCOPE	HRX	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
August 21, 2007	K072175	TITANIUM HIP TOOL LOCKING PLATE	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
January 4, 2007	K063709	TS-BONE HIP TOOL	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
November 1, 2006	K063033	MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
October 7, 2005	K052538	S-BONE HIP TOOL	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
May 23, 2005	K051181	CUSTOM-HIP TOOL	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
May 23, 2005	K051032	TITANIUM-HIP TOOL	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
September 3, 2004	K040493	OUTOLOGOUS SPINAL FIXATION SYSTEM	MNI	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
June 24, 2004	K040850	TSY SHOULDER PLATE IMPLANT	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov
September 23, 2002	K022139	HIP TOOL IMPLANT	HRS	Substantially Equivalent	Orthopedic Sciences, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 3, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.