PedFlex Flexible Nailing System 00-1001-0531-S

GUDID 00840194419444

PediFlex Clamp SS, 3.0mm Left

ORTHOPEDIATRICS CORP.

Femur intramedullary nail

• Primary Device ID: 00840194419444
• NIH Device Record Key: 63be2844-34de-4f02-982c-5e57f37fbfdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PedFlex Flexible Nailing System
• Version Model Number: 00-1001-0531-S
• Catalog Number: 00-1001-0531-S
• 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: true
• Expiration Date: true
• 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(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com
• Phone: +1(574)268-6379
• Email: xxx@xxx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840194419444 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251362

FDA Product Code

• HTY: PIN, FIXATION, SMOOTH

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-10
• Device Publish Date: 2025-07-02

On-Brand Devices [PedFlex Flexible Nailing System]

• 00841132198384: Ø4.0 MM X 450 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198377: Ø3.5 MM X 400 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198360: Ø3.0 MM X 400 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198353: Ø2.5 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198346: Ø2.0 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198339: Ø1.5 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198322: Ø4.5 MM X 450 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198315: Ø4.0 MM X 450 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198308: Ø3.5 MM X 400 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198292: Ø3.0 MM X 400 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198285: Ø2.5 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198278: Ø2.0 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198261: Ø1.5 MM X 300 MM ROUND TIP FLEXIBLE IM NAIL
• 00841132198193: Ø4.5 MM FLEXIBLE IM NAIL CAP (2 EACH)
• 00841132198186: Ø4.0 MM FLEXIBLE IM NAIL CAP (2 EACH)
• 00841132198179: Ø3.5 MM FLEXIBLE IM NAIL CAP (2 EACH)
• 00841132198162: Ø3.0 MM FLEXIBLE IM NAIL CAP (2 EACH)
• 00841132198155: Ø2.5 MM FLEXIBLE IM NAIL CAP (2 EACH)
• 00841132198148: Ø2.0 MM FLEXIBLE IM NAIL CAP (2 EACH)
• 00841132198063: Round tip 4.5mm x 450mm Ti
• 00841132198056: Round tip 4.0mm x 450mm Ti
• 00841132198049: Round tip 3.5mm x 400mm Ti
• 00841132198032: Round tip 3.0mm x 400mm Ti
• 00841132198025: Round tip 2.5mm x 300mm Ti
• 00841132198018: Round tip 2.0mm x 300mm Ti
• 00841132198001: Round tip 1.5mm x 300mm Ti
• 00841132197998: Round tip 4.0mm x 450mm SS
• 00841132197981: Round tip 3.5mm x 400mm SS
• 00841132197974: Round tip 3.0mm x 400mm SS
• 00841132197967: Round tip 2.5mm x 300mm SS
• 00841132197950: Round tip 2.0mm x 300mm SS
• 00841132197943: Round tip 1.5mm x 300mm SS
• 00841132100080: Ø4.0 MM X 450 MM FLEXIBLE IM NAIL
• 00840194419628: PediFlex Clamp Ti, 4.5mm Left
• 00840194419611: PediFlex Clamp Ti, 4.5mm Right
• 00840194419604: PediFlex Clamp Ti, 4.0mm Left
• 00840194419598: PediFlex Clamp Ti, 4.0mm Right
• 00840194419581: PediFlex Clamp Ti, 3.5mm Left
• 00840194419574: PediFlex Clamp Ti, 3.5mm Right
• 00840194419567: PediFlex Clamp Ti, 3.0mm Left
• 00840194419550: PediFlex Clamp Ti, 3.0mm Right
• 00840194419543: PediFlex Clamp screw Ti, 35mm
• 00840194419536: PediFlex Clamp screw Ti, 25mm
• 00840194419529: PediFlex Clamp screw Ti, 15mm
• 00840194419512: PediFlex Clamp screw SS, 35mm
• 00840194419505: PediFlex Clamp screw SS, 25mm
• 00840194419499: PediFlex Clamp screw SS, 15mm
• 00840194419482: PediFlex Clamp SS, 4.0mm Left
• 00840194419475: PediFlex Clamp SS, 4.0mm Right
• 00840194419468: PediFlex Clamp SS, 3.5mm Left