HSD

Product Code: HSD


Products Classified as HSD

4468Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedShoulder Joint Humeral (hemi-shoulder) Metallic Uncemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4468Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedShoulder Joint Humeral (hemi-shoulder) Metallic Uncemented Prosthesis.

FDA Consensus Standards

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented [37410]21 CFR §888.3690 🔎
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented [37411]21 CFR §888.3690 🔎
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented [35610]21 CFR §888.3690 🔎
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented [37433]21 CFR §888.3690 🔎
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented [37814]21 CFR §888.3690 🔎

Pre-market Notifications for HSD

K221232Univers Revers Humeral Cup ImplantArthrex Inc.
K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC.
K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.
K161782Arthrex Univers Revers Shoulder Prosthesis SystemARTHREX, INC.
K161620Anatomical Shoulder Domelock Dome CentricZIMMER GMBH
K151527Arthrex Univers Revers CA Heads And AdaptersARTHREX, INC.
K142942HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemARTHROSURFACE INC.
K131298EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEMEXACTECH, INC.
K130759HUMELOCK II CEMENTLESS SHOULDER SYSTEMFX SOLUTIONS
K130675ARTHREX UNIVERS II CA HEADSARTHREX, INC.
K130635SEVIIN SURFACE REPLACEMENT SHOULDERINGEN ORTHOPEDICS LLC
K121714SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTSSMITH & NEPHEW, INC.
K112983SPACER-STECRES SPA
K112900SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADSLIMACORPORATE S.P.A.
K111097HUMELOCK CEMENTED SHOULDER PROSTHESISFX SOLUTIONS

Global Unique Device Identification Database

00814193025326Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
00814193025319Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
00814193025302Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
00814193025296Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
00814193025289Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
00190446323006PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446284420PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446284376PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446259190PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446259176PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446259152PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446259107PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446257714PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446257707PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
00190446257660PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Maude Adverse Events

GLOBAL UNITE HEAD 48X18 ECCDEPUY IRELAND - 96166712020-03-31
UNK ZIMMER BIGLIANI FLATOWZIMMER BIOMET, INC.2020-03-30
UNK TAPER ADAPTERZIMMER BIOMET, INC.2020-03-27
GLBL UNITE ANT BODY 135 SZ 10DEPUY ORTHOPAEDICS INC US2020-03-26
DXTEND GLENOSPHERE STD D38MMDEPUY FRANCE SAS - 30038955752020-03-24
DXTEND STAND PE CUP D38 +3MMDEPUY FRANCE SAS - 30038955752020-03-24
UNKNOWN SHOULDER LOCKING SCREWDEPUY ORTHOPAEDICS INC US2020-03-23
UNKNOWN SHOULDER LOCKING SCREWDEPUY ORTHOPAEDICS INC US2020-03-23
UNKNOWN GLENOID BEARINGZIMMER BIOMET, INC.2020-03-20
UNKNOWN GLENOSPHEREZIMMER BIOMET, INC.2020-03-20
HUMERISFX SOLUTIONS2020-03-20
HUMELOCK IIFX SOLUTIONS2020-03-20
HUMERISFX SOLUTIONS2020-03-20
HUMELOCK IIFX SOLUTIONS2020-03-20
HUMLOCK IIFX SOLUTIONS2020-03-20
HUMERISFX SOLUTIONS2020-03-20
HUMELOCK IIFX SOLUTIONS2020-03-19
HUMERISFX SOLUTIONS2020-03-17
HUMELOCK IIFX SOLUTIONS2020-03-17
HUMELOCK IIFX SOLUTIONS2020-03-17
HUMERISFX SOLUTIONS2020-03-16
HUMELOCK IIFX SOLUTIONS2020-03-16
HUMELOCK IIFX SOLUTIONS2020-03-16
HUMELOCK IIFX SOLUTIONS2020-03-16
DXTEND GLENOSPHERE STD D42MMDEPUY FRANCE SAS - 30038955752020-03-16
DXTEND SCREW LOCK D4.5X36MMDEPUY FRANCE SAS - 30038955752020-03-13
DXTEND HUMERAL SPACER +9MMDEPUY FRANCE SAS - 30038955752020-03-13
XTNDGLENO ECCD42MM+0MM SHRTPSTDEPUY FRANCE SAS - 30038955752020-03-13
HUMELOCK IIFX SOLUTIONS2020-03-13
HUMERISFX SOLUTIONS2020-03-12
DXTEND SCREW LOCK D4.5X30MMDEPUY FRANCE SAS - 30038955752020-03-11
DXTEND SCREW LOCK D4.5X30MMDEPUY FRANCE SAS - 30038955752020-03-11
GLOBAL ADVANTAGE CTA HD 52X23DEPUY ORTHOPAEDICS INC US2020-03-10
HUMELOCK IIFX SOLUTIONS2020-03-10
GLOBAL UNITE HEAD 44X18 ECCDEPUY IRELAND - 96166712020-03-09
POLY LINER PLUS 6 MM OFFSET 36 MM DIAMETERZIMMER BIOMET, INC.2020-03-06
UNKNOWN GLENOID COMPONENTZIMMER BIOMET, INC.2020-03-06
TAYLOR RT PM MINI RVS GLEN HAZIMMER BIOMET, INC.2020-03-05
AEQUALIS GLENOID AND REVERSED PIN2020-03-05
HUMERAL HEAD SIZE 46DEPUY ORTHOPAEDICS INC US2020-03-04
ANCHOR PLATE SIZE 46DEPUY ORTHOPAEDICS INC US2020-03-04
DXTEND GLENOSPHERE STD D38MMDEPUY FRANCE SAS - 30038955752020-03-04
DXTEND STAND PE CUP D38 +6MMDEPUY FRANCE SAS - 30038955752020-03-04
HUMERISFX SOLUTIONS2020-03-04
DXTEND GLENOSPHERE STD D38MMDEPUY FRANCE SAS - 30038955752020-03-02
HUMERISFX SOLUTIONS2020-03-02
DXTEND SCREW LOCK D4.5X36MMDEPUY FRANCE SAS - 30038955752020-02-28
UNKNOWN HUMERAL STEMZIMMER BIOMET, INC.2020-02-28
DXTEND GLENOSPHERE ECC D42MMDEPUY FRANCE SAS - 30038955752020-02-28
DXTEND STAND PE CUP D38 +3MMDEPUY FRANCE SAS - 30038955752020-02-27
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