Pediatric Nailing Platform | Tibia 00-1510-7355

GUDID 00840194423182

PNP Tibia 7mm x 355mm Nail

ORTHOPEDIATRICS CORP.

Tibia nail

• Primary Device ID: 00840194423182
• NIH Device Record Key: 1ca21c21-add8-4c9b-a772-85431540d059
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Nailing Platform | Tibia
• Version Model Number: 00-1510-7355
• Catalog Number: 00-1510-7355
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194423182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231266

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

[00840194423182]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-25
• Device Publish Date: 2023-09-15

On-Brand Devices [Pediatric Nailing Platform | Tibia]

• 00841132123546: REAMER HEAD, Ø12.0 MM
• 00841132123539: REAMER HEAD, Ø11.5 MM
• 00841132123522: REAMER HEAD, Ø11.0 MM
• 00841132123515: REAMER HEAD, Ø10.5 MM
• 00841132123508: REAMER HEAD, Ø10.0 MM
• 00841132123492: REAMER HEAD, Ø9.5 MM
• 00841132123485: REAMER HEAD, Ø9.0 MM
• 00841132123478: REAMER HEAD, Ø8.5 MM
• 00841132123461: REAMER HEAD, Ø8.0 MM
• 00841132123454: REAMER HEAD, Ø7.5 MM
• 00841132123447: FLEXIBLE IM REAMER SHAFT 18IN
• 00840194463003: PNP Tibia X-RaFalse Template Set
• 00840194462808: Ball Level, 6.0mm Pin
• 00840194462792: Ball Level, 3.2mm Pin
• 00840194462747: PNP Tibia Rapid Alignment Tool
• 00840194462730: PNP Tibia - Outer Shell Lid
• 00840194462723: PNP Tibia - Instrument Case 2 Upper TraFalse
• 00840194462716: PNP Tibia - Instrument Case 2 Lower TraFalse
• 00840194462693: PNP Tibia - Instrument Case 1 Upper TraFalse
• 00840194462686: PNP Tibia - Instrument Case 1 Lower TraFalse
• 00840194462662: Nitinol Flex Shaft, 625mm
• 00840194462655: 8.5mm Monobloc Nitinol Reamer, 625mm
• 00840194462648: 8.0mm Monobloc Nitinol Reamer, 625mm
• 00840194462631: 7.5mm Monobloc Nitinol Reamer, 625mm
• 00840194462624: 7.0mm Monobloc Nitinol Reamer, 625mm
• 00840194462617: 6.5mm Monobloc Nitinol Reamer, 625mm
• 00840194462600: 6.0mm Monobloc Nitinol Reamer, 625mm
• 00840194462594: PNP XL Reamer Case Lid
• 00840194462587: PNP XL Reamer Case
• 00840194446112: PNP Retaining End Cap Driver, ZH QC
• 00840194446105: PNP Tibia Nail Measurement Tool
• 00840194446099: Ball Hex Driver, ZH QC
• 00840194446068: PNP Tibia - 12mm Nail TraFalse
• 00840194446051: PNP Tibia - 11mm Nail TraFalse
• 00840194446044: PNP Tibia - 10mm Nail TraFalse
• 00840194446037: PNP Tibia - 9mm Nail TraFalse
• 00840194446020: PNP Tibia - 8mm Nail TraFalse
• 00840194446013: PNP Tibia - 7mm Nail TraFalse
• 00840194446006: PNP Tibia - Outer Shell
• 00840194445993: PNP Tibia - Screw CaddFalse Lid
• 00840194445986: PNP Tibia - Screw CaddFalse
• 00840194445979: Tapered Screw Driver, 4.0 Hex, Long, ZH QC
• 00840194445962: PNP Tibia Cannulated End Cap 12mm x 20mm
• 00840194445955: PNP Tibia Cannulated End Cap 12mm x 15mm
• 00840194445948: PNP Tibia Cannulated End Cap 12mm x 10mm
• 00840194445931: PNP Tibia Cannulated End Cap 12mm x 5mm
• 00840194445924: PNP Tibia Cannulated End Cap 11mm x 20mm
• 00840194445917: PNP Tibia Cannulated End Cap 11mm x 15mm
• 00840194445900: PNP Tibia Cannulated End Cap 11mm x 10mm
• 00840194445894: PNP Tibia Cannulated End Cap 11mm x 5mm