INHANCE 510021522

GUDID 10603295549185

INHANCE SHOULDER SYSTEM HYBRID UNITI GLENOID X-SMALL Ø21.5mm CEMENTED CAUTION:INTENDED FOR CEMENTED USE ONLY

DEPUY (IRELAND)

Shoulder glenoid fossa prosthesis, prefabricated

• Primary Device ID: 10603295549185
• NIH Device Record Key: 9b4a93d4-edcc-4ca7-b8ba-6a816f679825
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INHANCE
• Version Model Number: 5100-21-522
• Catalog Number: 510021522
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295549185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212933

FDA Product Code

• PAO: prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-08
• Device Publish Date: 2023-02-28

On-Brand Devices [INHANCE]

• 10603295546146: INHANCE SHOULDER SYSTEM TRIAL INSTRUMENT CASE COMPLETE
• 10603295546139: INHANCE SHOULDER SYSTEM GENERAL INSTRUMENT CASE COMPLETE
• 10603295546122: INHANCE SHOULDER SYSTEM CIRCULAR GLENOID REAMER CADDY COMPLETE
• 10603295546115: INHANCE SHOULDER SYSTEM BOWTIE GLENOID REAMER CADDY COMPLETE
• 10603295539650: INHANCE SHOULDER SYSTEM SHARK FIN OSTEOTOME
• 10603295539643: INHANCE SHOULDER SYSTEM HEAD DISTRACTOR
• 10603295539513: INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE X-LARGE
• 10603295539506: INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE LARGE
• 10603295539490: INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE MEDIUM
• 10603295539483: INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE SMALL
• 10603295539476: INHANCE SHOULDER SYSTEM GLENOID REAMER - BOWTIE X-SMALL
• 10603295539445: INHANCE SHOULDER SYSTEM TAPER AND SHELL EXTRACTOR TIP
• 10603295539438: INHANCE SHOULDER SYSTEM DRIVER HANDLE
• 10603295539421: INHANCE SHOULDER SYSTEM DRIVER
• 10603295539414: INHANCE SHOULDER SYSTEM CONVEX IMPACTOR TIP
• 10603295539407: INHANCE SHOULDER SYSTEM CONCAVE IMPACTOR TIP
• 10603295539391: INHANCE SHOULDER SYSTEM STAR DRIVER 30
• 10603295539384: INHANCE SHOULDER SYSTEM IMPACTOR HANDLE
• 10603295539377: INHANCE SHOULDER SYSTEM HUMERAL PIN GUIDE
• 10603295539360: INHANCE SHOULDER SYSTEM TRIAL HUMERAL HEAD OFFSET TAPER ADAPTER
• 10603295539353: INHANCE SHOULDER SYSTEM STEM INSERTER BOLT
• 10603295539346: INHANCE SHOULDER SYSTEM STEM INSERTER
• 10603295539339: INHANCE SHOULDER SYSTEM CANNULATED IMPACTOR HANDLE
• 10603295539322: INHANCE SHOULDER SYSTEM HUMERAL STEM PATHFINDER
• 10603295539315: INHANCE SHOULDER SYSTEM HUMERAL STEM PIN PUNCH
• 10603295539308: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 57mm X 24mm
• 10603295539292: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 57mm X 20.5mm
• 10603295539285: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 54mm X 22mm
• 10603295539278: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 54mm X 19mm
• 10603295539261: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 51mm X 20.5mm
• 10603295539254: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 51mm X 18mm
• 10603295539247: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 48.5mm X 19.5mm
• 10603295539230: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 48.5mm X 17mm
• 10603295539223: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 46mm X 18.5mm
• 10603295539216: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 46mm X 16mm
• 10603295539209: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 44mm X 17.25mm
• 10603295539193: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 44mm X 15.25mm
• 10603295539186: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 42mm X 16.5mm
• 10603295539179: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 42mm X 14.5mm
• 10603295539162: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 40mm X 15.75mm
• 10603295539155: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 40mm X 13.75mm
• 10603295539148: INHANCE SHOULDER SYSTEM HUMERAL HEAD TRIAL diameter 38mm X 13.5mm
• 10603295539131: INHANCE SHOULDER SYSTEM HUMERAL SIZER X-LARGE diameter 44mm
• 10603295539124: INHANCE SHOULDER SYSTEM HUMERAL SIZER LARGE diameter 40mm
• 10603295539117: INHANCE SHOULDER SYSTEM HUMERAL SIZER MEDIUM diameter 36mm
• 10603295539100: INHANCE SHOULDER SYSTEM HUMERAL SIZER SMALL diameter 32mm
• 10603295539094: INHANCE SHOULDER SYSTEM HUMERAL SIZER X-SMALL diameter 28mm
• 10603295539087: INHANCE SHOULDER SYSTEM HUMERAL BLAZER X-LARGE diameter 44mm
• 10603295539070: INHANCE SHOULDER SYSTEM HUMERAL BLAZER LARGE diameter 40mm
• 10603295539063: INHANCE SHOULDER SYSTEM HUMERAL BLAZER MEDIUM diameter 36mm