Pediatric Nailing Platform | Tibia 00-1524-0050

GUDID 00840194427074

PNP 4.0mm x 50mm Fully Threaded Screw, Ti

ORTHOPEDIATRICS CORP.

Tibia nail
Primary Device ID00840194427074
NIH Device Record Keyb37dbb69-e520-4816-80af-1fce792e8aa7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePediatric Nailing Platform | Tibia
Version Model Number00-1524-0050
Catalog Number00-1524-0050
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840194427074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

[00840194427074]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-25
Device Publish Date2023-09-15

On-Brand Devices [Pediatric Nailing Platform | Tibia]

00841132123546REAMER HEAD, Ø12.0 MM
00841132123539REAMER HEAD, Ø11.5 MM
00841132123522REAMER HEAD, Ø11.0 MM
00841132123515REAMER HEAD, Ø10.5 MM
00841132123508REAMER HEAD, Ø10.0 MM
00841132123492REAMER HEAD, Ø9.5 MM
00841132123485REAMER HEAD, Ø9.0 MM
00841132123478REAMER HEAD, Ø8.5 MM
00841132123461REAMER HEAD, Ø8.0 MM
00841132123454REAMER HEAD, Ø7.5 MM
00841132123447FLEXIBLE IM REAMER SHAFT 18IN
00840194463003PNP Tibia X-RaFalse Template Set
00840194462808Ball Level, 6.0mm Pin
00840194462792Ball Level, 3.2mm Pin
00840194462747PNP Tibia Rapid Alignment Tool
00840194462730PNP Tibia - Outer Shell Lid
00840194462723PNP Tibia - Instrument Case 2 Upper TraFalse
00840194462716PNP Tibia - Instrument Case 2 Lower TraFalse
00840194462693PNP Tibia - Instrument Case 1 Upper TraFalse
00840194462686PNP Tibia - Instrument Case 1 Lower TraFalse
00840194462662Nitinol Flex Shaft, 625mm
008401944626558.5mm Monobloc Nitinol Reamer, 625mm
008401944626488.0mm Monobloc Nitinol Reamer, 625mm
008401944626317.5mm Monobloc Nitinol Reamer, 625mm
008401944626247.0mm Monobloc Nitinol Reamer, 625mm
008401944626176.5mm Monobloc Nitinol Reamer, 625mm
008401944626006.0mm Monobloc Nitinol Reamer, 625mm
00840194462594PNP XL Reamer Case Lid
00840194462587PNP XL Reamer Case
00840194446112PNP Retaining End Cap Driver, ZH QC
00840194446105PNP Tibia Nail Measurement Tool
00840194446099Ball Hex Driver, ZH QC
00840194446068PNP Tibia - 12mm Nail TraFalse
00840194446051PNP Tibia - 11mm Nail TraFalse
00840194446044PNP Tibia - 10mm Nail TraFalse
00840194446037PNP Tibia - 9mm Nail TraFalse
00840194446020PNP Tibia - 8mm Nail TraFalse
00840194446013PNP Tibia - 7mm Nail TraFalse
00840194446006PNP Tibia - Outer Shell
00840194445993PNP Tibia - Screw CaddFalse Lid
00840194445986PNP Tibia - Screw CaddFalse
00840194445979Tapered Screw Driver, 4.0 Hex, Long, ZH QC
00840194445962PNP Tibia Cannulated End Cap 12mm x 20mm
00840194445955PNP Tibia Cannulated End Cap 12mm x 15mm
00840194445948PNP Tibia Cannulated End Cap 12mm x 10mm
00840194445931PNP Tibia Cannulated End Cap 12mm x 5mm
00840194445924PNP Tibia Cannulated End Cap 11mm x 20mm
00840194445917PNP Tibia Cannulated End Cap 11mm x 15mm
00840194445900PNP Tibia Cannulated End Cap 11mm x 10mm
00840194445894PNP Tibia Cannulated End Cap 11mm x 5mm
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