FDA.reportPublic FDA data

INHANCE SHOULDER SYSTEM

Primary DI
10603295551928
Brand
INHANCE SHOULDER SYSTEM
Company
DEPUY (IRELAND)
Model
7702-20-600
Catalog number
770220600
Device description
INHANCE SHOULDER SYSTEM HUMERAL PREP KIT EXTRA LARGE NA
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOREAMER
HTQBROACH
KIJInstrument, surgical, orthopedic, dc-powered motor and accessory/attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1
HTQBroachOrthopedic1
KIJInstrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295551928PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329555192810603295551928

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, single-useA collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
989365556
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295541325ATTUNE1518-20-1051518201052021-08-27
10603295541332ATTUNE1518-20-1061518201062021-08-27
10603295541349ATTUNE1518-20-1071518201072021-08-27
10603295541356ATTUNE1518-20-1081518201082021-08-27
10603295541363ATTUNE1518-20-1101518201102021-08-27
10603295541370ATTUNE1518-20-1121518201122021-08-27
10603295541387ATTUNE1518-20-1141518201142021-08-27
10603295541394ATTUNE1518-20-1161518201162021-08-27
10603295541400ATTUNE1518-20-2051518202052021-08-27
10603295541417ATTUNE1518-20-2061518202062021-08-27
10603295541424ATTUNE1518-20-2071518202072021-08-27
10603295541431ATTUNE1518-20-2081518202082021-08-27
10603295541448ATTUNE1518-20-2101518202102021-08-27
10603295541455ATTUNE1518-20-2121518202122021-08-27
10603295541462ATTUNE1518-20-2141518202142021-08-27
10603295541479ATTUNE1518-20-2161518202162021-08-27
10603295541486ATTUNE1518-20-3051518203052021-08-27
10603295541493ATTUNE1518-20-3061518203062021-08-27
10603295541509ATTUNE1518-20-3071518203072021-08-27
10603295541516ATTUNE1518-20-3081518203082021-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190446913214DJO SURGICALEncore Medical, L.P.HTQ2026-10-21
00190446913221DJO SURGICALEncore Medical, L.P.HTQ2026-10-21
00190446913979DJO SURGICALEncore Medical, L.P.HTQ2026-10-21
00810111227919BROACHTreace Medical Concepts, Inc.HTQ2026-09-30
00810111227926BROACHTreace Medical Concepts, Inc.HTQ2026-09-30
00810111227933BROACHTreace Medical Concepts, Inc.HTQ2026-09-30
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTO2026-08-03
00850056900119Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900126Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900133Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900140Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900157Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00850056900164Insurgical, Inc.Insurgical, Inc.KIJ2025-11-25
00860007230004Insurgical, Inc.Insurgical, Inc.KIJ2025-01-17
00860007230028Insurgical, Inc.Insurgical, Inc.KIJ2025-01-17
00860007230035Insurgical, Inc.Insurgical, Inc.KIJ2025-01-17
00810112598049Keel Lock Implant SystemCROSSROADS EXTREMITY SYSTEMSHTQ2024-07-31
00810112598537DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598544DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598551DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598568DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598575DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598599DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598605DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598612DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598629DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112598636DynaFORCE Staple InstrumentsCROSSROADS EXTREMITY SYSTEMSHTO2024-07-31
00810112592269TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592276TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23
00810112592283TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHTO2024-02-23