Data / Medical devices / United States / NuVasive Specialized Orthopedics, Inc.

NuVasive Specialized Orthopedics, Inc.: FDA-registered device maker in Audubon, PA, United States, 42 510(k) clearances

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

NuVasive Specialized Orthopedics, Inc. is registered with the FDA (registration 3006179046) in Audubon, PA, United States. It lists 23 device types. The FDA files 42 510(k) clearances under its listings, the newest dated February 6, 2024. 7 recall events name it as the recalling firm. 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 NuVasive Specialized Orthopedics, Inc.

FDA registration number: 3006179046
Address: 2560 General Armistead Ave VALLEY FORGE BUSINESS CENTER, Audubon, PA, United States, 19403
Owner or operator: NUVASIVE, INC. (9036345)
Roles: Manufacturer, Manufacturer for export
First device listed: November 2, 2006
Registered through: 2026
Brand names listed: Awl, BIT, DRILL, DRIVER, PROSTHESIS, ERC 3P, EXTRACTOR, External Remote Controller ERC 4P, GAUGE, DEPTH, General Instruments and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Manufacturer	accessdata.fda.gov
Awl	HWJ	1	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Driver, Prosthesis	HWR	1	Manufacturer	accessdata.fda.gov
Elevator	HTE	1	Manufacturer	accessdata.fda.gov
Extractor	HWB	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Growing Rod System- Magnetic Actuation	PGN	2	Manufacturer	accessdata.fda.gov
Impactor	HWA	1	Manufacturer	accessdata.fda.gov
Instrument, Compression	HWN	1	Manufacturer	accessdata.fda.gov
Mallet	HXL	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Manufacturer	accessdata.fda.gov
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	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
February 6, 2024	K233593	MAGEC Spinal Bracing and Distraction System	PGN	Substantially Equivalent	Nuvasive Specialized Orthopedics, Incorporated	accessdata.fda.gov
December 15, 2023	K232267	Precice Max System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Incorporated	accessdata.fda.gov
August 29, 2023	K230765	Precice Ankle Salvage System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
March 15, 2023	K220234	Precice Intramedullary Limb Lengthening System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
December 22, 2020	K202348	External Remote Controller ERC 4P	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
September 16, 2020	K200430	Precice® Ankle Salvage System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
August 10, 2020	K201567	Precice® Bone Transport System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
July 30, 2020	K201543	MAGEC® System	PGN	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
May 8, 2020	K193617	Precice® Screws	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
May 8, 2020	K193016	PRECICE Bone Transport System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
November 7, 2019	K192181	PRECICE Plating System	KTT	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
September 26, 2019	K191336	PRECICE System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
February 5, 2019	K182170	PRECICE® BONE TRANSPORT System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
April 3, 2018	K180503	PRECICE STRYDE System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
September 25, 2017	K172628	PRECICE System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
August 31, 2017	K171791	MAGEC® System	PGN	Substantially Equivalent	Nuvasive Specialized Orthopedics, Incorporated	accessdata.fda.gov
August 24, 2017	K172061	PRECICE UNYTE System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
June 9, 2017	K170169	PRECICE Intramedullary Limb Lengthening System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
April 6, 2017	K162927	PRECICE UNYTE CoCr System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
March 7, 2017	K170346	PRECICE Intramedullary Limb Lengthening System	HSB	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
October 21, 2016	K160352	MAGEC® Spinal Bracing and Distraction System	PGN	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
September 2, 2016	K161751	MAGEC® Spinal Bracing and Distraction System	PGN	Substantially Equivalent	Nuvasive Specialized Orthopedics, Inc.	accessdata.fda.gov
April 4, 2016	K160325	PRECICE Intramedullary Limb Lengthening System	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
March 31, 2016	K160267	PRECICE Trauma Nail System	HSB	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
January 25, 2016	K151594	Ellipse Supplemental Instrument Trays	KCT	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
December 22, 2015	K152370	PRECICE Trauma Nail System	HSB	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
June 19, 2015	K151131	PRECICE Intramedullary Limb Lengthening System	HSB	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
May 29, 2015	K150885	MAGEC 2 Spinal Bracing and Distraction System	PGN	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
April 23, 2015	K150656	PRECICE Intramedullary Limb Lengthening System	HSB	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
March 24, 2015	K141278	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	PGN	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
January 16, 2015	K142599	PRECISE Trauma Nail System	HSB	Substantially Equivalent	Ellipse Technologies, Incorporated	accessdata.fda.gov
October 7, 2014	K141739	RESIDUAL LIMB LENGTHENING SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
September 18, 2014	K140613	MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	PGN	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
June 30, 2014	K141447	PRECICE TRAUMA NAIL SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
May 20, 2014	K141023	PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
February 27, 2014	K140178	ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM	PGN	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
January 23, 2014	K131490	ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
December 9, 2013	K133289	PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
October 11, 2013	K131677	PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
October 19, 2012	K113219	ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
March 28, 2012	K113695	ELLIPSE PRECICE TRAUMA NAIL SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov
July 12, 2011	K101997	ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM	HSB	Substantially Equivalent	Ellipse Technologies, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 30, 2024	95567	Class II	Ongoing	Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm PM10.0-80B305 PRECICE MAX Antegrade Femur Pirifor	Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.	accessdata.fda.gov
November 1, 2022	91125	Class II	Ongoing	NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm	During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the device is no longer sterile.	accessdata.fda.gov
October 29, 2021	89001	Class II	Ongoing	NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA105	The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.	accessdata.fda.gov
February 12, 2021	87353	Class II	Ongoing	NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System End Cap for PRECICE Intramedullary Limb Lengthening System Implant; Packaged End Cap 8.5/10.7mm, +0mm; Packaged End Cap 8.5/10.7mm, +5mm; Package	Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old.	accessdata.fda.gov
February 12, 2021	87352	Class II	Ongoing	PRECICE STRYDE - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.	Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.	accessdata.fda.gov
July 24, 2020	86150	Class II	Ongoing	NUVASIVE SPECIALIZED ORTHOPEDICS, INC. Precice Bone Transport Antegrade Femur Trochanter 10 Degree Bend Component of the orthopedic Precice Bone Transport System of intramedullary nail, locking screws, reusable instrumen	During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system.	accessdata.fda.gov
June 25, 2019	89177	Class II	Ongoing	MAGEC 1 System	Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.	accessdata.fda.gov

Compare with other makers

Updated November 21, 2024. 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.