FDA.reportPublic FDA data

NA

Primary DI
00810004721920
Brand
NA
Company
Integrity Implants Inc.
Model
ASY-00701
Catalog number
ASY-00701
Device description
Hudson to 1/4 Drive Adaptor
Published
2021-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810004721920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810004721920008100047219208100047219200810004721920

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/instrument adaptor, reusableA connecting device designed to join an implant to a surgical instrument or a surgical instrument to another instrument particularly to create an extension or to connect two devices where the interfaces of the devices are not compatible. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This device can be used, e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800.201.9300customerservice@integrityimplants.com

Regulatory Flags#

DUNS number
080300717
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810004722507NAASY-00181ASY-001812020-06-03
00810004722514NAASY-00182ASY-001822020-06-03
00810004722491NAASY-00180ASY-001802019-10-07
00810004722521NAASY-00267ASY-002672019-10-07
00810004722538NAASY-00268ASY-002682019-10-07
00810004722545NAASY-00269ASY-002692019-10-07
00810004722552NAASY-00270ASY-002702019-10-07
00810004722569NAASY-00183ASY-001832019-10-07
00810004722576NAASY-00184ASY-001842019-10-07
00810004722736NAASY-00272ASY-002722019-10-07
00810004722743NAASY-00273ASY-002732019-10-07
00840200409926FlareHawkFHTPWB52025-10-02
00840200410595LineSiderASY-001962025-10-02
00840200410656NACMP-03002CMP-030022025-07-17
00810045531014FlareHawkFHTPCS0026TTSFHTPCS0026TTS2022-12-08
00810045531021FlareHawkFHTPCT0026TTSFHTPCT0026TTS2022-12-08
00810045531038FlareHawkFHTPCS0030TTSFHTPCS0030TTS2022-12-08
00810045531045FlareHawkFHTPCT0030TTSFHTPCT0030TTS2022-12-08
00840200407984FlareHawkFHTGCS0023TTFHTGCS0023TT2023-10-16
00840200407991FlareHawkFHTGCT0023TTFHTGCT0023TT2023-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900022EARP INITIAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900039EARP FINAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900046RETRACTABLE OSTEOTOMERETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900053EARP BLADE 100RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900060EARP BLADE 110RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900077EARP BLADE 120RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900084EARP BLADE 130RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900091EARP BLADE 140RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900107EARP BLADE 150RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900114EARP BLADE 160RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900121EARP BLADE 170RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900138EARP BLADE 180RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900145EARP BLADE 190RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900152EARP CRADLE ASSEMBLYRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900169EARP RETRACTOR CONNECTORRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900183EARP CUFF TRIAL 3&4MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900190EARP CUFF TRIAL 5&6MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900206EARP, TRIAL 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900213EARP, TRIAL 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900220EARP, TRIAL 14X35X10 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900237EARP, TRIAL 18X35X8 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900244EARP, TRIAL 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900251EARP, TRIAL 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900268EARP, TRIAL 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900275EARP, TRIAL 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900282EARP, TRIAL 18X35X12 14°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900299EARP, TRIAL 22X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900343EARP DISC SPACER, 8MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15