LCP 442507

GUDID H6794425070

2.4MM TI LCP(TM) DISTAL RADIUS L-PLATE/-90DEG 3H HD/4H SHAFT

Synthes GmbH

Orthopaedic fixation plate, non-bioabsorbable, sterile

Primary Device ID	H6794425070
NIH Device Record Key	2f2ac00b-4583-4d6a-9c4a-0744859aa9d5
Commercial Distribution Status	In Commercial Distribution
Brand Name	LCP
Version Model Number	442.507
Catalog Number	442507
Company DUNS	486711679
Company Name	Synthes GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
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Phone	+1(800)255-2500
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Phone	+1(800)255-2500
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Phone	+1(800)255-2500
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Phone	+1(800)255-2500
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Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx
Phone	+1(800)255-2500
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982222992 [Primary]
HIBCC	H6794425070 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K012114

FDA Product Code

HRS	PLATE, FIXATION, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

[H6794425070]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2022-05-02
Device Publish Date	2015-09-14

On-Brand Devices [LCP]

H679031230110	INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/LT
H679031230100	INSERTION GUIDE F/3.5MM LCP PERIARTIC PROX HUMERUS PL/RT
07611819334458	AIMING ARM F/LCP PROXIMAL HUMERUS PLATE
07611819391710	COUPLING BOLT FOR LCP PERIARTICULAR AIMING ARMS
07611819979611	STOPPER FOR LCP PERIARTICULAR AIMING ARMS-LARGE
07611819970144	SCALPEL HANDLE F/LCP PERIART AIMING INSTRUMENT SET-LARGE
07611819970120	LOCK NEUTRAL GUIDE FOR LCP PERIARTIC AIMING SYSTEM/LARGE
07611819978294	PERIARTICULAR AIMING ARM F/4.5MM LCP CONDYLAR PLATE 8H
07611819978287	PERIARTICULAR AIMING ARM F/4.5MM LCP CONDYLAR PLATE 18H
07611819978270	PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-LT
07611819970113	PERIARTICULAR INSERTION HANDLE F/4.5MM LCP CONDYLAR PL-LEFT
07611819978263	PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-RT
07611819970007	PERIARTICULAR INSERTION HANDLE F/4.5MM LCP CONDYLAR PL-RIGHT
07611819969995	COUPLING BOLT F/OBLIQUE AIMING GUIDE F/LCP PERIART AIMING AR
07611819969988	OBLQUE AIM GUIDE F/PERIART ARM F/4.5MM LCP PROX TIBIA PL-LT
07611819978256	PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-LT
07611819969964	OBLQUE AIM GUIDE F/PERIART ARM F/4.5MM LCP PROX TIBIA PL-RT
07611819978249	PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-RT
07611819393981	THREADED BENDING PIN FOR 1.5MM LCP PLATES
H679031140010	1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES
07611819405394	DEPTH GAUGE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
H679031130170	STOPPER FOR 3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
07611819348639	PULL REDUCTION DEVICE F/3.5MM LCP PERCUTANEOUS INSTR SYS
07611819405387	SCALPEL HANDLE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
07611819334373	TROCAR W/HANDLE F/3.5MM LCP PERCUTANEOUS INSTRUMENT SYSTEM
07611819403727	AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/LEFT
07611819403703	AIMING ARM F/3.5MM LCP LOW BND MEDIAL DISTAL TIBIA PL/RIGHT
H679031119050	SAW GUIDE FOR 2.7MM LCP ULNA OSTEOTOMY PLATE
07611819412880	OSTEOTOMY MEASURING DEVICE FOR 2.7MM PEDIATRIC LCP HIP PL
07611819412767	PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 2.7MM SCREWS
07611819888876	MEDIALIZATION GUIDE FOR 3.5MM & 5.0MM LCP PLATES
07611819847224	PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 5.0MM SCREWS
07611819847217	PEDIATRIC LCP HIP PLATE GUIDING BLOCK FOR 3.5MM SCREWS
H67902161290S0	3.5MM CURVED BROAD LCP PLATE/30 HOLE-STERILE
H679021612900	3.5MM CURVED BROAD LCP PLATE/30 HOLE
H67902161288S0	3.5MM CURVED BROAD LCP PLATE/28 HOLE-STERILE
H679021612880	3.5MM CURVED BROAD LCP PLATE/28 HOLE
H67902161286S0	3.5MM CURVED BROAD LCP PLATE/26 HOLE-STERILE
H679021612860	3.5MM CURVED BROAD LCP PLATE/26 HOLE
H67902161284S0	3.5MM CURVED BROAD LCP PLATE/24 HOLE-STERILE
H679021612840	3.5MM CURVED BROAD LCP PLATE/24 HOLE
H67902161282S0	3.5MM CURVED BROAD LCP PLATE/22 HOLE-STERILE
H679021612820	3.5MM CURVED BROAD LCP PLATE/22 HOLE
H67902161280S0	3.5MM CURVED BROAD LCP PLATE/20 HOLE-STERILE
H679021612800	3.5MM CURVED BROAD LCP PLATE/20 HOLE
H67902161278S0	3.5MM CURVED BROAD LCP PLATE/18 HOLE-STERILE
H679021612780	3.5MM CURVED BROAD LCP PLATE/18 HOLE
H67902161276S0	3.5MM CURVED BROAD LCP PLATE/16 HOLE-STERILE
H679021612760	3.5MM CURVED BROAD LCP PLATE/16 HOLE
H67902161274S0	3.5MM CURVED BROAD LCP PLATE/14 HOLE-STERILE

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