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Integra Pain Management: FDA-registered device maker in West Valley City, UT, United States, 11 510(k) clearances

Name: Integra Pain Management FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Integra Pain Management is registered with the FDA (registration 1722447) in West Valley City, UT, United States. It lists 18 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 7, 2018. 14 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1722447
FEI number: 1000138491
Address: 3498 West 2400 South #1050, West Valley City, UT, United States, 84119
Owner or operator: Integra LifeSciences Corporation (9004007)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: April 24, 1981
Registered through: 2026
Brand names listed: CRW, CRW Biopsy Plus, CRW Precision Arc Steriotactic System, CRW-1 System, CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA, CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA, CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602, Codman Leroy Raney Scalp Bulk and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Cast	ITG	1	Contract manufacturer	accessdata.fda.gov
Cannula, Surgical, General & Plastic Surgery	GEA	1	Manufacturer	accessdata.fda.gov
Clip, Scalp	HBO	2	Manufacturer	accessdata.fda.gov
Curette, Adenoid	KBJ	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Dermatome	GFD	1	Manufacturer	accessdata.fda.gov
Drills, Burrs, Trephines & Accessories (Manual)	HBG	2	Manufacturer	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Manufacturer	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Manufacturer	accessdata.fda.gov
Knife, Ent	KTG	1	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Neurological Stereotaxic Instrument	HAW	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Neurosurgical Ultrasonic Instruments	LBK	U	Manufacturer	accessdata.fda.gov
Percussor	GWZ	1	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
Screw, Oral	KBW	1	Repackager or relabeler	accessdata.fda.gov
Sound, Uterine	HHM	1	Repackager or relabeler	accessdata.fda.gov
Table And Attachments, Operating-Room	BWN	1	Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Ent	MMO	1	Repackager or relabeler	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
December 7, 2018	K182809	CUSA Clarity Ultrasonic Surgical Aspirator System	LFL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
December 6, 2016	K160811	CRW STEREOTACTIC SYSTEM	HAW	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
October 14, 2016	K161882	CUSA Clarity Ultrasonic Surgical Aspirator System	LFL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
November 6, 2014	K141674	CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM	LFL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
September 7, 2007	K072208	MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS	HBL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
June 13, 2007	K071458	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	HBL	Substantially Equivalent	Integra LifeSciences Corporation	accessdata.fda.gov
September 15, 2003	K032054	RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE	HAW	Substantially Equivalent	Radionics, A Division of Tyco Healthcare Group LP	accessdata.fda.gov
June 5, 1996	K961113	CNS INTERCHANGEABLE BIT CRANIAL DRILL	HBG	Substantially Equivalent	Clinical Neuro Systems, LLC	accessdata.fda.gov
December 6, 1995	K941558	MAYFIELD CHILD DISPOSABLE SKULL PIN	HBL	Substantially Equivalent	Ohio Medical Instrument Co., Inc.	accessdata.fda.gov
September 28, 1993	K932860	MAYFIELD ADULT DISPOSABLE SKULL PIN	HBL	Substantially Equivalent	Ohio Medical Instrument Co., Inc.	accessdata.fda.gov
February 12, 1993	K923789	MAYFIELD ADULT DISPOSABLE SKULL PIN	HBL	Substantially Equivalent	Ohio Medical Instrument Co., 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
August 24, 2016	75029	Class II	Terminated	PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, loca	Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.	accessdata.fda.gov
August 24, 2016	75028	Class II	Terminated	Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND	Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.	accessdata.fda.gov
August 4, 2016	74867	Class II	Terminated	INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.	Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays.	accessdata.fda.gov
September 22, 2015	72274	Class II	Terminated	Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % L	Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within	accessdata.fda.gov
May 1, 2015	71147	Class II	Terminated	Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Int	Integra LifeSciences Corp. d.b.a. Integra Pain Management Announces Voluntary Recall of Tuohy Needles (20 Gauge, 5 inch) due to incorrect packaging (labeled as 18 Gauge, 3. 5 inch).	accessdata.fda.gov
March 30, 2015	70873	Class II	Terminated	Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850. Used to administer steroid medication in the epidural space.	A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.	accessdata.fda.gov
November 26, 2013	66949	Class II	Terminated	Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used	Integra LifeSciences is voluntarily recalling any unexpired lots of HITHSP10 Cranial Access Kits due to identified labeling discrepancies. kit contains DuraPrep and Monocryl sutures whose labeling does not align with the intended use and labeling of the Cranial Access Kit.	accessdata.fda.gov
October 28, 2013	66885	Class II	Terminated	Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit	Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.	accessdata.fda.gov
September 4, 2013	66186	Class II	Terminated	Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an ex	Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.	accessdata.fda.gov
June 7, 2012	61525	Class III	Terminated	Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthes	Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.	accessdata.fda.gov
December 21, 2011	60798	Not yet classified	Terminated	1104HC Integra NeuroSciences Ventricular Bold Monitoring Kit W/ Cranial Access, Drain including (1) Cranial Kit W/Cam. Chuck, (1) Ventricular Bolt ICP Monitoring Kit, (1) CSF Drainage System. Contains Sterile and Non-Ste	Current package insert was revised to include additional warning information related to the potential hazards of an unapproved off-label use of Xylocaine.	accessdata.fda.gov
July 13, 2009	52683	Not yet classified	Terminated	Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B, Integra LifeSciences Corporation, Salt Lake City, Utah 84104. Kits contain syringes, drugs, sponges, drapes and other products supplied by outsid	Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.	accessdata.fda.gov
July 7, 2008	48971	Not yet classified	Terminated	Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.0, SSR1-7.5, SSR1-8.0, Integra Pain Management, 3395 West 1820 South, Salt Lake City, Utah 84104.	Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.	accessdata.fda.gov
March 18, 2008	47373	Not yet classified	Terminated	Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791	Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.	accessdata.fda.gov

Compare with other makers

Updated December 7, 2018. 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.