Product Code: JDR


Products Classified as JDR

4531Staple, Fixation, BoneSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

Total Product Life Cycle (TPLC) Devices

4531Staple, Fixation, BoneSingle/multiple Component Metallic Bone Fixation Appliances And Accessories.

FDA Consensus Standards

Staple, Fixation, Bone [37410]21 CFR §888.3030 🔎
Staple, Fixation, Bone [37411]21 CFR §888.3030 🔎
Staple, Fixation, Bone [37811]21 CFR §888.3030 🔎
Staple, Fixation, Bone [37429]21 CFR §888.3030 🔎
Staple, Fixation, Bone [38369]21 CFR §888.3030 🔎

Pre-market Notifications for JDR

K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC.
K220812DynaClip® Bone StapleMedShape, Inc.
K220181StealthFix Intraosseous Fixation SystemNextremity Solutions, Inc.
K210582EasyClip® And EasyClip® XpressStryker GmbH
K210482Medline UNITE REFLEX Nitinol Staple SystemMedline Industries, Inc.
K210456Ligament StapleMedacta International SA
K203832FuseForceâ„¢ Flex Dynamic Compression SystemWright Medical
K203180Arthrex DynaNite Nitinol StaplesArthrex Inc.
K193305DynaClip Bone StapleMedShape, Inc.
K192447Superelastic StapleNeosteo
K191636APTUS Foot SystemMedartis AG
K191463DePuy Synthes Hammertoe Continuous Compression ImplantSynthes (USA) Products, LLC
K190722TriMAX Implant SystemCrossRoads Extemity Systems, LLC
K190166TriMed Nitinol Staple SystemTriMed, Inc.
K182943VERTEX Nitinol Staple SystemNvision Biomedical Technologies, LLC

Global Unique Device Identification Database

00721902671838STAPLE, FIXATION, BONE
00721902671814STAPLE, FIXATION, BONE
00721902671784STAPLE, FIXATION, BONE
00721902662645STAPLE, FIXATION, BONE
00810633022023Staple, Fixation, Bone
00810633022016Staple, Fixation, Bone
00810633022009Staple, Fixation, Bone
00810633021996Staple, Fixation, Bone
00810633021811Staple, Fixation, Bone
00810633021804Staple, Fixation, Bone
00810633021798Staple, Fixation, Bone
00810633021781Staple, Fixation, Bone
00810633021774Staple, Fixation, Bone
00810633021767Staple, Fixation, Bone
00810633021750Staple, Fixation, Bone

Maude Adverse Events

SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-31
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JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
JAWS NITINOL STAPLE SYSTEMPARAGON 28, INC.2020-03-27
SPEED COMPRESSION IMPLANT KIT 18X18X18MMOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-26
STAPLE, FIXATION, BONECROSSROADS EXTREMITY SYSTEMS2020-03-25
STAPLE, FIXATION, BONECROSSROADS EXTREMITY SYSTEMS2020-03-25
STAPLE, FIXATION, BONECROSSROADS EXTREMITY SYSTEMS2020-03-25
JGRKNT 2.9MM #2 BLUE MB SNGL NGLEZIMMER BIOMET, INC.2020-03-23
SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20X20MM OFFSET 8MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-20
SPEED COMPRESSION IMPLANT KIT 11X10X10MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-20
SPEED COMPRESSION IMPLANT KIT 11X10X10MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-03-20
GII QA+ #2 ETH CP-2 *EADEPUY MITEK LLC US2020-03-19
GII QA+ #2 ETH CP-2 *EADEPUY MITEK LLC US2020-03-19
GII QA+ #2 ETH CP-2 *EADEPUY MITEK LLC US2020-03-19
GII QA+ #2 ETH CP-2 *EADEPUY MITEK LLC US2020-03-19
4.9MM HEALX ADV SP BIOC ANCHORMEDOS INTERNATIONAL SàRL2020-03-13
TOGGLELOC XL WITH ZIPLOOPZIMMER BIOMET, INC.2020-02-28
TRIMAX 18MM PREP KITCROSSROADS EXTREMITY SYSTEMS2020-02-26
FIX STPL W/SPKE 18X23 LRGSMITH & NEPHEW, INC.2020-02-21
FIX STPL W/SPKE 18X23 LRGSMITH & NEPHEW, INC.2020-02-21
ELITE COMPRESSION IMPLANT 25X20X20X20X20 4 LEGSWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-19
SPEED COMPRESSION IMPLANT KIT 15X12X12MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-02-17
SUPER QA+ #2 PAN CP-2 *EADEPUY MITEK LLC US2020-02-13
SUPER QA+ #2 PAN CP-2 *EADEPUY MITEK LLC US2020-02-13
SUPER QA+ #2 PAN CP-2 *EADEPUY MITEK LLC US2020-02-13
SUPER QA+ #2 PAN CP-2 *EADEPUY MITEK LLC US2020-02-13
JUGGERKNOT 1.4MM 1 #1 MB 10PKZIMMER BIOMET, INC.2020-02-04
TWINFIX TI 3.5 ULTRABRAIDSMITH & NEPHEW, INC.2020-02-03
GII QA+ O/C CP-2 *EADEPUY MITEK LLC US2020-01-30
SPEED DRILL KIT WITH 2.65MM DRILL BITOBERDORF SYNTHES PRODUKTIONS GMBH2020-01-30
SUPER QA+ O/C DS CP-2 *EADEPUY MITEK LLC US2020-01-30
SUPER QA+ O/C DS CP-2 *EADEPUY MITEK LLC US2020-01-29
10MM X 10MM X 10MM STAPLETRILLIANT SURGICAL2020-01-28
GII EASY ARTHRO #2 ETH *EADEPUY MITEK LLC US2020-01-24
TWINFIX TI 5.0 ULTRABRAIDSMITH & NEPHEW, INC.2020-01-23
SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20MM OFFSET 6MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-17
ARCUS STAPLE SYSTEMNEXTREMITY SOLUTIONS2020-01-15
GII QA+ #2 PAN CP-2 *EADEPUY MITEK LLC US2020-01-15
SPEED COMPRESSION IMPLANT KIT 13X10X10MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2020-01-14
SUPER QA+ #2 ETH CP-2 *EADEPUY MITEK LLC US2020-01-02
SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20MM OFFSET 6MMWRIGHTS LANE SYNTHES USA PRODUCTS LLC2019-12-11
MINI TAC TI 2.0 SUTURE ANCH W/TWO DURASMITH & NEPHEW, INC.2019-11-28
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