13 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·May 14, 2025
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·April 16, 2025
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height 17 mm Eccentric LOW (1.5) Material PyC/CoCr, e) Catalog # DWH048 - Diameter 48 mm Height 18 mm Eccentric LOW (1.5) Material PyC/CoCr, f) Catalog # DWH050 - Diameter 50 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, g) Catalog # DWH051 - Diameter 50 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, h) Catalog # DWH052 - Diameter 52 mm Height 19 mm Eccentric LOW (1.5) Material PyC/CoCr, i) Catalog # - DWH053 - Diameter 52 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, j) Catalog # DWH054 - Diameter 54 mm Height 23 mm Eccentric LOW (1.5) Material PyC/CoCr, k) Catalog # DWH139 - Diameter 39 mm Height 14 mm Eccentric HIGH (3.5) Material PyC/CoCr, l) Catalog # DWH141 - Diameter 41 mm Height 15 mm Eccentric HIGH (3.5) Material PyC/CoCr, m) Catalog # DWH143 - Diameter 43 mm Height 16 mm Eccentric HIGH (3.5) Material PyC/CoCr, n) Catalog # DWH146 - 46 mm Height 17 mm Eccentric HIGH (4) Material PyC/CoCr, o) Catalog # DWH148, - Diameter 48 mm Height 18 mm Eccentric HIGH (4) Material PyC/CoCr, p) Catalog # DWH150 - Diameter 50 mm Height 16 mm Eccentric HIGH (4) Material PyC/CoCr, q) Catalog # DWH151 - Diameter 50 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, r) Catalog # DWH152 - Diameter 52 mm Height 19 mm Eccentric HIGH (4) Material PyC/CoCr, s) Catalog # DWH153 - Diameter 52 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr, t) Catalog # DWH154 - Diameter 54 mm Height 23 mm Eccentric HIGH (4) Material PyC/CoCr,
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·August 25, 2021
Stryker Blueprint Software, Catalog #BPUE001.
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·May 29, 2024
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
FDA Enforcement
Class II
·Ongoing·Tornier S.A.S.·January 22, 2025