FDA.reportPublic FDA data

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

Definition
A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.
GUDID devices
19,659
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00888867266865Arthrex®ARTHREX, INC.AR-8952DFS-S2017-08-01
10381780064329Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.SPIDERSET2015-08-15
10381780064343Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.VIPERSET2015-08-15
10381780064497Construct® Ankle Fusion Plate SystemAscension Orthopedics, Inc.AFPIMP2015-09-22
10381780064572"Integra® Total Foot System"""Ascension Orthopedics, Inc.TARSALISIMP2017-10-09
10381780064589"Integra® Total Foot System"""Ascension Orthopedics, Inc.TFSFOREFTIMP2015-09-22
10381780064596"Integra® Total Foot System"""Ascension Orthopedics, Inc.TFSREARFTIMP2015-09-22
10381780064633"Integra® Total Foot System"""Ascension Orthopedics, Inc.FFMFOOTIMP2015-09-22
10381780064640"Integra® Total Foot System"""Ascension Orthopedics, Inc.RFOOTIMP2015-09-22
10381780064657Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0600052017-10-09
10381780064664Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0600062017-10-09
10381780064671Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0628062017-10-09
10381780064688Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0628082017-10-09
10381780064695Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0628102017-10-09
10381780064701Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0628122017-10-09
10381780064718Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0628142017-10-09
10381780064725Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0628162017-10-09
10381780064732Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0628182017-10-09
10381780064749Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0700052017-10-09
10381780064756Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0700062017-10-09
10381780064763Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0724082017-10-09
10381780064770Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0724102017-10-09
10381780064787Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0724122017-10-09
10381780064794Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0724142017-10-09
10381780064800Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0728062017-10-09
10381780064824Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0728102017-10-09
10381780064848Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0728142017-10-09
10381780064862Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.0728182017-10-09
10381780064923Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427102017-10-09
10381780064930Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427122017-10-09
10381780064947Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427142017-10-09
10381780064954Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427162017-10-09
10381780064961Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427182017-10-09
10381780064978Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427202017-10-09
10381780064985Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427222017-10-09
10381780065005Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427082017-10-09
10381780065012Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427242017-10-09
10381780065029Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427262017-10-09
10381780065036Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427282017-10-09
10381780065043Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427302017-10-09
10381780065050Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427322017-10-09
10381780065067Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427342017-10-09
10381780065074Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427362017-10-09
10381780065081Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.271427382017-10-09
10381780065098Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.280064012017-10-09
10381780065104Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.280064022017-10-09
10381780065111Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.280066012017-10-09
10381780065128Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.280066022017-10-09
10381780065135Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.28135082017-10-09
10381780065142Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.281350102017-10-09
10381780065159Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.281350122017-10-09
10381780065166Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.281350142017-10-09
10381780065173Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.281350162017-10-09
10381780065180Viper® Distal Volar Radius Plating SystemAscension Orthopedics, Inc.281350182017-10-09
10381780065197Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3031002017-10-09
10381780065203Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3031012017-10-09
10381780065210Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3031022017-10-09
10381780065227Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032102017-10-09
10381780065234Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032122017-10-09
10381780065241Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032142017-10-09
10381780065258Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032162017-10-09
10381780065265Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032182017-10-09
10381780065272Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032202017-10-09
10381780065289Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032222017-10-09
10381780065296Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3032242017-10-09
10381780065302Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033122017-10-09
10381780065319Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033142017-10-09
10381780065326Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033162017-10-09
10381780065333Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033182017-10-09
10381780065340Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033202017-10-09
10381780065357Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033222017-10-09
10381780065364Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033242017-10-09
10381780065371Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033262017-10-09
10381780065388Integra® Total Wrist Fusion SystemAscension Orthopedics, Inc.3033282017-10-09
10381780441373Integra® Spider™ Limted Wrist Fusion SystemAscension Orthopedics, Inc.SPIDERIMP2018-05-11
10806378031731ACUMEDAcumed LLC70-00072015-10-24
10806378031755ACUMEDAcumed LLC70-00082015-10-24
10806378031779ACUMEDAcumed LLC70-00092015-10-24
10806378031793ACUMEDAcumed LLC70-00102015-10-24
10806378031816ACUMEDAcumed LLC70-00112015-10-24