Product Code: HRS


Products Classified as HRS

4461Plate, Fixation, BoneSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

Total Product Life Cycle (TPLC) Devices

4461Plate, Fixation, BoneSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

FDA Consensus Standards

Plate, Fixation, Bone [37410]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37411]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37861]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37390]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [34069]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37811]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37429]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37448]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37830]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [30912]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37432]21 CFR §888.3030 ๐Ÿ”Ž
Plate, Fixation, Bone [37813]21 CFR §888.3030 ๐Ÿ”Ž

Pre-market Notifications for HRS

K222637TriMed Wrist Fixation System 3TriMed, Inc.
K222282HEMC BRAND Locking Bone Plates And Screws Osteosynthesis Plating SystemHospital Equipment Manufacturing Company
K222244Arthrex 3.5 Mm Locking Compression PlatesArthrex Inc.
K222194Baby Gorillaยฎ/Gorillaยฎ Plating SystemParagon 28, Inc.
K221920ARIX Small Fragment SystemJeil Medical Corporation
K221809DePuy Synthes 3.5mm Intrapelvic Acetabular SystemDePuy Synthes
K221465Baby Gorilla/Gorilla Plating SystemParagon 28, Inc.
K221412ARIX Rib SystemJeil Medical Corporation
K221395Footmotion Plating SystemNewclip Technics
K221362Omni Foot And Ankle Plating SystemExremity Medical, LLC.
K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH
K220937Arthrex Mini Fragment SystemArthrex Inc.
K220463Osteotomy Truss System (OTS)4WEB Medical, Inc.
K220244DVRยฎ Crosslock Wrist Spanning Plate (131849181)Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech
K220199AFFINITY Proximal Tibia SystemTechfit Digital Surgery INC.

Global Unique Device Identification Database

00613994840301PLATE, FIXATION, BONE
00613994284655PLATE, FIXATION, BONE
00613994284648PLATE, FIXATION, BONE
00613994284631PLATE, FIXATION, BONE
00613994284624PLATE, FIXATION, BONE
00613994284617PLATE, FIXATION, BONE
00613994284600PLATE, FIXATION, BONE
00613994284594PLATE, FIXATION, BONE
00613994284587PLATE, FIXATION, BONE
00643169620766Plate, fixation, bone
00643169620759Plate, fixation, bone
00643169620742Plate, fixation, bone
00643169620735Plate, fixation, bone
00643169620728Plate, fixation, bone
00643169620711Plate, fixation, bone

Maude Adverse Events

UNK - PLATES: 4.5 MM LCP CONDYLAR PLATEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
STERNALOCK 360 MULTI-IMPLANT SYSTEMBIOMET MICROFIXATION2020-03-31
STERNALOCK 360 MULTI-IMPLANT SYSTEMBIOMET MICROFIXATION2020-03-31
UNK - PLATES: MATRIXNEUROWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - PLATES: TUBULARWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNK - PLATES: THORACOLUMBAR SPINE LOCKING PLATE (TSLP)OBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - PLATES: THORACOLUMBAR SPINE LOCKING PLATE (TSLP)OBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
3.5MM LCP SUPERIOR CLAVICLE PLATE/6 HOLE/RIGHT/85MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
UNKNOWN ANCHORAGE LOW PROFILE TITANIUM PLATESTRYKER GMBH2020-03-31
UNKNOWN ANCHORAGE LOW PROFILE TITANIUM PLATESTRYKER GMBH2020-03-30
UNKNOWN LOCKING SCREWSTRYKER GMBH2020-03-30
UNK - PLATES: 3.5 MM LCP CLAVICLE HOOK PLATEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
2.7 MM CORTICAL SCREW SELF-TAPPING 14 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM CORTICAL SCREW SELF-TAPPING 14 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM CORTICAL SCREW SELF-TAPPING 14 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM CORTICAL SCREW SELF-TAPPING 14 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.0 MM CORTICAL SCREW SELF-TAPPING WITH HEXAGONAL RECESS 48 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM CORTICAL SCREW SELF-TAPPING 14 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM CORTICAL SCREW SELF-TAPPING 16 MM LENGTHZIMMER BIOMET, INC.2020-03-30
3.5 MM CORTICAL SCREW SELF-TAPPING 26 MM LENGTHZIMMER BIOMET, INC.2020-03-30
3.5 MM PELVIC CORTICAL SCREW SELF-TAPPING 80 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.0 MM CORTICAL SCREW SELF-TAPPING WITH HEXAGONAL RECESS 46 MM LENGTHZIMMER BIOMET, INC.2020-03-30
3.5 MM CORTICAL SCREW SELF-TAPPING 45 MM LENGTHZIMMER BIOMET, INC.2020-03-30
3.5 MM CORTICAL SCREW SELF-TAPPING 24 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM CORTICAL SCREW SELF-TAPPING 12 MM LENGTHZIMMER BIOMET, INC.2020-03-30
3.5 MM CORTICAL SCREW SELF-TAPPING 28 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM COMPRESSION PLATE 6 HOLES 52 MM LENGTHZIMMER BIOMET, INC.2020-03-30
DISTAL LATERAL TIBIAL PLATE RIGHT 10 HOLES 142 MM LENGTHZIMMER BIOMET, INC.2020-03-30
2.7 MM LOCKING SCREW 12 MM LENGTHZIMMER BIOMET, INC.2020-03-30
PLATE, FIXATION, BONEWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-30
UNK - PLATES: CMFOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-30
UNK - PLATES: SPINEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-27
UNKNOWN NON-LOCKING SCREWSTRYKER GMBH2020-03-27
UNKNOWN ANCHORAGE LOW PROFILE TITANIUM PLATESTRYKER GMBH2020-03-27
TIMESH 6 X SCREWS, SELF-DRILLING (SDS), CRUCIATEMEDTRONIC NEUROSURGERY2020-03-27
2.7 MM LOCKING SCREW 18 MM LENGTHZIMMER BIOMET, INC.2020-03-27
TWIST DRILLKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-03-26
LEVEL ONE CMFKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-03-26
LEVEL ONE THORACICKARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG2020-03-26
HIP SCREW PLATE, DYNAMIC,130, 4 HOLESZIMMER GMBH2020-03-26
UNK - PLATES: FNSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-26
4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFTWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-26
4.5MM LCP PROXIMAL FEMUR HOOK PLATE 10 HOLES/277MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-25
3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 26MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-25
CORTSCR 3.5 SELF-TAP L40 TANOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-25
. 3.5MM TI STARDRIVE CORTEX . SCREW SELF-TAPPING 30MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-25
3.5MM TI STARDRIVE CORTEX SCREW SELF-TAPPING 26MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-25
V-TEK PLATE EXTREMITIESZIMMER GMBH2020-03-25
TI LCP? ONE-THIRD TUBULAR PLATE W/COLLAR 8 HOLES/93MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-25
UNK - PLATES: FNSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-24

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