SEVIIN FRACTURE SHOULDER
INGEN ORTHOPEDICS LLC
INGEN ORTHOPEDICS LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005130928 | 3005130928 | INGEN ORTHOPEDICS LLC | 1 | N | 2026-01-01 | 68 Mussey Road Scarborough ME US 04074 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 64986 | 1077687685 | K120374 | SEVIIN REVERSE SHOULDER | PHX | 2012-07-09 |
| 64986 | 1636734295 | K043346 | GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 | KWS | 2005-01-31 |
Product Codes Associated With Registrations#
PMN#
SEVIIN SURFACE REPLACEMENT SHOULDER
INGEN ORTHOPEDICS LLC
SEVIIN REVERSE SHOULDER
INGEN ORTHOPEDICS LLC
GUDID#
Ingen SEVIIN® Shoulder System - HUMERAL STEM, SIZE 1 STANDARD, 6 MM DIA X 100 MM LONG
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL STEM, SIZE 2 STANDARD, 8 MM DIA X 110 MM LONG
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL STEM, SIZE 3 STANDARD, 10 MM DIA X 120 MM LONG
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL STEM, SIZE 4 STANDARD, 12 MM DIA X 120 MM LONG
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL STEM, SIZE 5 STANDARD, 14 MM DIA X 125 MM LONG
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 40 MM DIA X 15 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 40 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 40 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 44 MM DIA X 15 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 44 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 44 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 48 MM DIA X 15 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 48 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 48 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 52 MM DIA X 15 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 52 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 52 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 56 MM DIA X 15 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 56 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, STANDARD, 56 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 44 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 44 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 48 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 48 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 52 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 52 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 56 MM DIA X 18 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - HUMERAL HEAD, OFFSET, 56 MM DIA X 21 MM HEIGHT
2019-03-20
Ingen SEVIIN® Shoulder System - GLENOID COMPONENT, X-SMALL, PEGGED
2019-03-20
Ingen SEVIIN® Shoulder System - GLENOID COMPONENT, SMALL, PEGGED
2019-03-20
Ingen SEVIIN® Shoulder System - GLENOID COMPONENT, MEDIUM, PEGGED
2019-03-20
Ingen SEVIIN® Shoulder System - GLENOID COMPONENT, LARGE, PEGGED
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE HUMERAL CUP, STANDARD
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE HUMERAL CUP, +9 MM
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE PE-INLAY, 36 MM DIA CENTERED, +0 MM
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE PE-INLAY, 36 MM DIA CENTERED, +3 MM
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE PE-INLAY, 36 MM DIA CENTERED, +6 MM
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +0 MM
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +3 MM
2019-03-20
Ingen SEVIIN® Shoulder System - REVERSE PE-INLAY, 36 MM DIA RETENTIVE, +6 MM
2019-03-20