Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1722447

FEI Number

1000138491

Entity Name

Integra Pain Management

City/State/Country

West Valley City, UT, US

Establishment Address

3498 WEST 2400 SOUTH, #1050, West Valley City, UT 84119, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Integra LifeSciences Corporation (Owner Number: 9004007)

Owner / Operator Contact Address

1100 Campus Rd, Princeton, NJ 08540, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA Mayfield Adult Disposable Skull Pin Integra Cranial Access Kit Codman Leroy Scalp Clip Adult Codman Leroy Scalp Clips Pediatric Codman Raney Scalp Clips Codman Leroy Raney Scalp Clips Codman Raney Scalp Clips Bulk Codman Leroy Raney Scalp Bulk Integra MicroFrance Cranial Access Kit Hand Drill MicroFrance Miltex Integra 33-100;4-410;4-411;4-412;4-415;4-420;4-421;4-422;4-423;4-510;4-511;4-512;4-515;4-515C;4-522 CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA Padgett Jarit MicroFrance Miltex Integra Mayfield Child Disposable Skull Pin MicroFrance Integra Mayfield Base Unit CRW-1 System CRW Precision Arc Steriotactic System CRW Mayfield Radiolucent Disposable Skull Pins Miltex Jarit Miltex Padgett MicroFrance Miltex Integra Jarit Jarit Integra Mayfield Titanium Skull Pins Reusab Mayfield Titanium Skull Pins Dispos Integra Padgett Padgett MicroFrance Integra

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-01-03
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2019-01-03
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2006-02-22
HBO	Clip, Scalp	Neurology	Class 2	882.4150	2008-02-25
MMO	Tray, Surgical, Ent	Ear, Nose, Throat	Class 1	874.4420	2015-03-28
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2008-01-08
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	1981-04-24
LBK	Neurosurgical Ultrasonic Instruments	Unknown	Class U	N/A	2016-10-21
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2016-10-21
EIG	Retractor, All Types	Dental	Class 1	872.4565	1981-04-24
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2015-03-30
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-12-21
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2008-01-04
KBW	Screw, Oral	Ear, Nose, Throat	Class 1	874.4420	1981-04-24
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1981-04-24
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2003-08-05
GWZ	Percussor	Neurology	Class 1	882.1700	2013-04-22
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2007-12-07
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2005-01-18
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2003-07-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Integra LifeSciences Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015194982	SURGICAL INNOVATION ASSOCIATES, INC.	Chicago, IL, US
3013505638	REBOUND THERAPEUTICS, CORPORATION	Irvine, CA, US
3006697299	INTEGRA LIFESCIENCES (IRELAND) LIMITED	SRAGH TULLAMORE Offaly, IE
2648988	INTEGRA NEUROSCIENCES	ANASCO, PR, US
9680837	INTEGRA MICROFRANCE SAS	SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K071458	Integra LifeSciences Corporation	MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS	2007-06-13
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1722447. Last updated year: 2026. Please use registration number 1722447 when referencing this establishment in official correspondence.