Locking Cannulated Blade Plate 00-1200-2504

GUDID 00841132132500

130° Locking Cannulated Infant Blade 45mm X 0mm X 3 hole

ORTHOPEDIATRICS CORP.

Growth-correction orthopaedic fixation plate kit Growth-correction orthopaedic fixation plate kit
Primary Device ID00841132132500
NIH Device Record Keyce2baed7-b3bb-4f75-aa22-49c4df2c5d8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameLocking Cannulated Blade Plate
Version Model Number00-1200-2504
Catalog Number00-1200-2504
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com
Phone+1(574)268-6379
EmailRbremer@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132132500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-31

On-Brand Devices [Locking Cannulated Blade Plate]

00841132136416TRAY 2 - MODULAR TRAY FOR LCB PLATES INSTRUMENT
00841132136409TRAY 6 - 130 DEG LCB PLATES, CHILD AND ADOLESCENT
00841132136393TRAY 5 - 90 DEG LCB PLATES, ADOLESCENT (4.5MM)
00841132136065TRAY 6: 130 DEGREE LOCKING CANNULATED BLADE PLATES, CHILD AND ADOLESCENT (3.5 AND 4.5 MM
00841132136058TRAY 5: 90 DEGREE LOCKING CANNULATED BLADE PLATES, ADOLESCENT (4.5 MM
00841132136041TRAY 4: 90 DEGREE LOCKING CANNULATED BLADE PLATES, INFANT AND CHILD (3.5 MM)
00841132136034TRAY 2: MODULAR TRAY FOR LOCKING CANNULATED BLADE PLATE INSTRUMENTATION
00841132136027PEDILOC LOCKING CANNULATED BLADE - 130° INFANT BASE
00841132136010LOCKING CANNULATED BLADE PLATE SYSTEM, INFANT BLADE 12 MM BASE
00841132135907PRECISION ANGLE WIRE GUIDE: NO HANDLE
00841132135891PRECISION ANGLE WIRE GUIDE AO TR
00841132135662100º LOCKING CANNULATED ADOLESCENT BLADE 70MM X 14MM X 4 HOLE
00841132135655100º LOCKING CANNULATED ADOLESCENT BLADE 65MM X 14MM X 4 HOLE
00841132135648100º LOCKING CANNULATED ADOLESCENT BLADE 60MM X 14MM X 4 HOLE
00841132135631100º LOCKING CANNULATED ADOLESCENT BLADE 55MM X 14MM X 4 HOLE
00841132135624100º LOCKING CANNULATED ADOLESCENT BLADE 50MM X 14MM X 4 HOLE
00841132135617100º LOCKING CANNULATED ADOLESCENT BLADE 45MM X 14MM X 4 HOLE
00841132135600100º LOCKING CANNULATED ADOLESCENT BLADE 40MM X 14MM X 4 HOLE
00841132134894LOCKING CANNULATED BLADE PLATE SYSTEM (4.5 INSTRUMENTS & SCREWS)
00841132134887LOCKING CANNULATED BLADE PLATE SYSTEM, 90°/130° ADOLESCENT IMPLANTS TRAY
00841132134870LOCKING CANNULATED BLADE PLATE SYSTEM, 4.5 INSTRUMENTS BASE
00841132134863LOCKING CANNULATED BLADE PLATE SYSTEM, 4.5 INSTRUMENTS TRAY
00841132134856LOCKING CANNULATED BLADE PLATE SYSTEM, 90°/130° ADOLESCENT IMPLANTS BASE
00841132134849LOCKING CANNULATED BLADE PLATE SYSTEM, 100°/130° CHILD IMPLANTS BASE
00841132134832LOCKING CANNULATED BLADE PLATE SYSTEM, 90° INFANT/CHILD IMPLANTS BASE
00841132134825LOCKING CANNULATED BLADE PLATE SYSTEM (3.5 INSTRUMENTS & SCREWS)
00841132134818BASE ASSEMBLY
00841132134801INSERT ASSEMBLY
00841132134795LID
00841132134788BLADE PLATE SET (INSTRUMENTS)
00841132134771LOCKING CANNULATED BLADE PLATE SYSTEM (4.5 SCREWS)
00841132134764LOCKING CANNULATED BLADE PLATE SYSTEM (3.5 SCREWS)
00841132134757LOCKING CANNULATED BLADE PLATE SYSTEM, 3.5 SCREW BASE
00841132134740LOCKING CANNULATED BLADE PLATE SYSTEM, 3.5 SCREW LID
00841132134733LOCKING CANNULATED BLADE PLATE SYSTEM, 4.5 SCREW BASE
00841132134726LOCKING CANNULATED BLADE PLATE SYSTEM, 4.5 SCREW LID
00841132134719BASE ASSEMBLY
00841132134702LID
00841132134696BLADE PLATE SET (SCREWS)
00841132134689LOCKING CANNULATED BLADE PLATE SYSTEM (90 DEG/130 DEG ADOLESCENT IMPLANTS)
00841132134672LOCKING CANNULATED BLADE PLATE SYSTEM (100 DEG/130DEG CHILD IMPLANTS)
00841132134665BASE ASSEMBLY
00841132134658INSERT ASSEMBLY
00841132134641ASSEMBLY
00841132134634LOCKING CANNULATED BLADE PLATE SYSTEM (90 DEG INFANT/CHILD IMPLANTS)
00841132134627BMP GUIDE (3.2MM DRILL BIT)
00841132134610OSTEOTOMY GAUGE W/45° EDGE, INFANT/CHILE
00841132134603OSTEOTOMY GUIDE W/45° EDGE
00841132134597THREADED INSERTER/ADOLESCENT:SMALL IMPACTION SURFACE (ADAPTS TO SLAP HAMMER)
00841132134580TRUNCATED TRIANGLE ANGLE GUIDE
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