Ingen SEVIIN® Shoulder System 102-48-21

GUDID B59910248210

HUMERAL HEAD, OFFSET, 48 MM DIA X 21 MM HEIGHT

INGEN ORTHOPEDICS, L.L.C.

Total shoulder prosthesis

• Primary Device ID: B59910248210
• NIH Device Record Key: 9cd84239-6756-455b-83a1-7eccea839125
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ingen SEVIIN® Shoulder System
• Version Model Number: 102-48-21
• Catalog Number: 102-48-21
• Company DUNS: 187232066
• Company Name: INGEN ORTHOPEDICS, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B59910248210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043346

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer 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: 2019-03-28
• Device Publish Date: 2019-03-20

On-Brand Devices [Ingen SEVIIN® Shoulder System]

• B59910702400: REVERSE BONE SCREW, 4.5 MM DIA X 40 MM LONG
• B59910702350: REVERSE BONE SCREW, 4.5 MM DIA X 35 MM LONG
• B59910702300: REVERSE BONE SCREW, 4.5 MM DIA X 30 MM LONG
• B59910702250: REVERSE BONE SCREW, 4.5 MM DIA X 25 MM LONG
• B59910702200: REVERSE BONE SCREW, 4.5 MM DIA X 20 MM LONG
• B59910702150: REVERSE BONE SCREW, 4.5 MM DIA X 15 MM LONG
• B59910701290: REVERSE METAGLENE PLATE, 29 MM
• B59910701250: REVERSE METAGLENE PLATE, 25 MM
• B59910640100: REVERSE GLENOSPHERE, 40 MM DIA, ECCENTRIC
• B59910640040: REVERSE GLENOSPHERE, 40 MM DIA, +4 MM
• B59910640000: REVERSE GLENOSPHERE, 40MM DIA, STANDARD
• B59910636100: REVERSE GLENOSPHERE, 36MM DIA, ECCENTRIC
• B59910636040: REVERSE GLENOSPHERE, 36MM DIA, +4 MM
• B59910636000: REVERSE GLENOSPHERE, 36MM DIA, STANDARD
• B59910601000: REVERSE GLENOSPHERE SCREW
• B59910540160: REVERSE PE-INLAY, 40 MM DIA RETENTIVE, +6 MM
• B59910540130: REVERSE PE-INLAY, 40 MM DIA RETENTIVE, +3 MM
• B59910540100: REVERSE PE-INLAY, 40 MM DIA RETENTIVE, +0 MM
• B59910540060: REVERSE PE-INLAY, 40 MM DIA CENTERED, +6 MM
• B59910540030: REVERSE PE-INLAY, 40 MM DIA CENTERED, +3 MM
• B59910540000: REVERSE PE-INLAY, 40 MM DIA CENTERED, +0 MM
• B59910536160: REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +6 MM
• B59910536130: REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +3 MM
• B59910536100: REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +0 MM
• B59910536060: REVERSE PE-INLAY, 36 MM DIA CENTERED, +6 MM
• B59910536030: REVERSE PE-INLAY, 36 MM DIA CENTERED, +3 MM
• B59910536000: REVERSE PE-INLAY, 36 MM DIA CENTERED, +0 MM
• B59910401090: REVERSE HUMERAL CUP, +9 MM
• B59910401000: REVERSE HUMERAL CUP, STANDARD
• B59910301030: GLENOID COMPONENT, LARGE, PEGGED
• B59910301020: GLENOID COMPONENT, MEDIUM, PEGGED
• B59910301010: GLENOID COMPONENT, SMALL, PEGGED
• B59910301000: GLENOID COMPONENT, X-SMALL, PEGGED
• B59910256210: HUMERAL HEAD, OFFSET, 56 MM DIA X 21 MM HEIGHT
• B59910256180: HUMERAL HEAD, OFFSET, 56 MM DIA X 18 MM HEIGHT
• B59910252210: HUMERAL HEAD, OFFSET, 52 MM DIA X 21 MM HEIGHT
• B59910252180: HUMERAL HEAD, OFFSET, 52 MM DIA X 18 MM HEIGHT
• B59910248210: HUMERAL HEAD, OFFSET, 48 MM DIA X 21 MM HEIGHT
• B59910248180: HUMERAL HEAD, OFFSET, 48 MM DIA X 18 MM HEIGHT
• B59910244210: HUMERAL HEAD, OFFSET, 44 MM DIA X 21 MM HEIGHT
• B59910244180: HUMERAL HEAD, OFFSET, 44 MM DIA X 18 MM HEIGHT
• B59910156210: HUMERAL HEAD, STANDARD, 56 MM DIA X 21 MM HEIGHT
• B59910156180: HUMERAL HEAD, STANDARD, 56 MM DIA X 18 MM HEIGHT
• B59910156150: HUMERAL HEAD, STANDARD, 56 MM DIA X 15 MM HEIGHT
• B59910152210: HUMERAL HEAD, STANDARD, 52 MM DIA X 21 MM HEIGHT
• B59910152180: HUMERAL HEAD, STANDARD, 52 MM DIA X 18 MM HEIGHT
• B59910152150: HUMERAL HEAD, STANDARD, 52 MM DIA X 15 MM HEIGHT
• B59910148210: HUMERAL HEAD, STANDARD, 48 MM DIA X 21 MM HEIGHT
• B59910148180: HUMERAL HEAD, STANDARD, 48 MM DIA X 18 MM HEIGHT
• B59910148150: HUMERAL HEAD, STANDARD, 48 MM DIA X 15 MM HEIGHT