FDA.reportPublic FDA data

INHANCE

Primary DI
10603295539346
Brand
INHANCE
Company
DEPUY (IRELAND)
Model
6201-01-151
Catalog number
620101151
Device description
INHANCE SHOULDER SYSTEM STEM INSERTER
Published
2021-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWAIMPACTOR
HWRDRIVER, PROSTHESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1
HWRDriver, ProsthesisOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295539346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329553934610603295539346

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
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
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24
10603295080145NA2001-80-5012001805012018-09-24
10603295080770NA2002-25-0002002250002018-09-24
10603295080787NA2002-27-0002002270002018-09-24
10603295080794NA2002-31-0002002310002018-09-24
10603295082057TRI-LOCK2012-03-0052012030052018-09-24
10603295082064TRI-LOCK2012-03-0102012030102018-09-24
10603295082071TRI-LOCK2012-03-0202012030202018-09-24
10603295082088TRI-LOCK2012-03-0302012030302018-09-24
10603295082095TRI-LOCK2012-03-0402012030402018-09-24
10603295082101TRI-LOCK2012-03-0502012030502018-09-24
10603295082118TRI-LOCK2012-03-0602012030602018-09-24
10603295082125TRI-LOCK2012-03-0702012030702018-09-24
10603295082132TRI-LOCK2012-03-0802012030802018-09-24
10603295082149TRI-LOCK2012-03-0902012030902018-09-24
10603295082156TRI-LOCK2012-03-1002012031002018-09-24
10603295082163TRI-LOCK2012-03-1102012031102018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
08809926260299InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260312InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260329InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260336InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260343InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260350InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260367InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260374InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260381InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260398InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
08809926260404InnoOrthoinnoOrtho Co., Ltd.HWR2026-06-01
G079C5070000120Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2026-04-22
07640332478462SCARLET® AC-TiSpineArt SAHWR2025-11-10
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295559436INHANCE INTACTDEPUY (IRELAND)HWR2025-06-13
10603295551768INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-03-07
10603295551805INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
10603295560050INHANCE SHOULDER SYSTEMDEPUY (IRELAND)HWR2025-02-21
G079C5080000040MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
G079C5080000160MIS Golden Isles Pedicle Screw System Intelivation, LLCHWR2023-10-03
00887868561368VersaNail®Biomet Orthopedics, LLCHWR2023-09-07
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
09348215083069Dual Mobility Sleeve DriverSIGNATURE ORTHOPAEDICS PTY LTDHWR2023-01-27
G079C5070000030Golden Isles Pedicle Screw SystemIntelivation, LLCHWR2022-09-23
10603295547631INHANCEDEPUY (IRELAND)HWR2022-05-16
10603295538912INHANCEDEPUY (IRELAND)HWR2021-08-30
10603295538943INHANCEDEPUY (IRELAND)HWR2021-08-30