HSN

Product Code: HSN


Products Classified as HSN

4470Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymerAnkle Joint Metal/polymer Semi-constrained Cemented Prosthesis.

Total Product Life Cycle (TPLC) Devices

4470Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymerAnkle Joint Metal/polymer Semi-constrained Cemented Prosthesis.

FDA Consensus Standards

Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer [34059]21 CFR §888.3110 🔎
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer [34070]21 CFR §888.3110 🔎
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer [37410]21 CFR §888.3110 🔎
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer [37411]21 CFR §888.3110 🔎
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer [38290]21 CFR §888.3110 🔎
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer [33111]21 CFR §888.3110 🔎
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer [38289]21 CFR §888.3110 🔎

Pre-market Notifications for HSN

K193067The INBONE™ Total Ankle System, The INFINITY™ Total Ankle System And The INVISION™ Total Ankle Revision SystemWright Medical Technology, Inc.
K192994Paragon 28 APEX 3D Total Ankle Replacement SystemParagon 28, Inc.
K191393INFINITY Total Ankle System, INBONE Total Ankle SystemWright Medical Technology, Inc.
K191380Quantum® Total Ankle ProsthesisIn2Bones SAS
K183343Vantage Total Ankle Flat Cut Talar ComponentsExactech Inc
K182878Integra Salto Total Ankle SystemAscension Orthopedics
K181557INFINITY Total Ankle SystemWright Medical Technology, Inc.
K180730INVISION Total Ankle Revision SystemWright Medical Technology, Inc.
K172633INFINITY Total Ankle SystemWright Medical Technology, Inc.
K171067INVISION Total Ankle Revision SystemWright Medical Technology, Inc.
K171004Hintermann Series H2 Total Ankle SystemDt MedTech LLC
K170968PROPHECY INVISION Pre-operative Navigation SystemWright Medical Technology, Inc.
K162795PROPHECY INVISION Preoperative Navigation Alignment SystemWright Medical Technology, Inc.
K153452Salto XT, Salto TalarisTornier SAS
K153008INVISION Total Ankle Revision SystemWright Medical Technology, Inc.

Global Unique Device Identification Database

B095422836Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422835Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422834Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422833Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422832Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422826Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422825Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422824Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422823Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422822Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422806Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422805Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422804Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422803Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
B095422802Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Maude Adverse Events

UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN TIBIAL COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN POLYETHYLENE COMPONENTSTRYKER GMBH2020-03-31
UNKNOWN ANKLE TIBIAL INSERTDEPUY ORTHOPAEDICS INC US2020-03-31
UNKNOWN POLYETHYLENE MENISCUS 6MMSTRYKER GMBH2020-03-30
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-26
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-24
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-24
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-24
UNKNOWN POLYETHYLENE LINERSTRYKER GMBH2020-03-24
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-24
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-19
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-19
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-19
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-12
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-10
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-10
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-05
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-05
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-05
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-03-04
UNKNOWN TALAR COMPONENTSTRYKER GMBH2020-03-03
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-26
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-26
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-26
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-26
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-26
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-25
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-20
INFINITY TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-20
INBONE TOTAL ANKLE SYSTEMWRIGHT MEDICAL TECHNOLOGY, INC.2020-02-14

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.