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

K213895Distal Humerus Plating SystemSkeletal Dynamics, Inc.
K213214Xpert WristNewclip Technics
K212841Pectus Blu Support Bar SystemBiomet Micofixation
K212640Stratumยฎ Ankle Fusion Plating SystemNextremity Solutions, Inc.
K212487CoLink Vallux Plating SystemIn2Bones USA, LLC
K212433Anthem Fracture SystemGlobus Medical Inc.
K212297Omni Foot And Ankle Plating SystemExtremity Medical, LLC.
K211695Valkyrie Thoracic Fixation SystemJM Longyear Manufacturing, LLC D/b/a Able Medical Devices
K211650The Radian MIS Bunion SystemNvision Biomedical Technologies, Inc
K211646FINE OsteotomyBodycad Laboratories, Inc.
K211592Avanti Orthopaedics Ulnar Shortening SystemAvanti Orthopaedics, Inc.
K211582LOQTEQ Proximal Humerus Plate 3.5 SystemAap Implantate AG
K211051DePuy Synthes 2.7mm Straight And 2.7mm Adaption Plates (Modular Mini Fragment LCP System)DePuy Synthes
K210750Acumed Clavicle Hook Plating SystemAcumed LLC
K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating SystemGramercy Extremity Orthopedics, LLC

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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