3P Hip System 01-3050-0050

GUDID 00840194497527

3P 5.0mm Screw Caddy

ORTHOPEDIATRICS CORP.

Instrument tray, reusable

• Primary Device ID: 00840194497527
• NIH Device Record Key: 47855e7e-e768-4cc0-b283-77031e2b8406
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3P Hip System
• Version Model Number: 01-3050-0050
• Catalog Number: 01-3050-0050
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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: false
• 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(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	00840194497527 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243963

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

[00840194497527]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-25
• Device Publish Date: 2025-08-15

On-Brand Devices [3P Hip System]

• 00841132190999: 3P 5.0mm Transphyseal Screw Caddy
• 00841132190982: 3P 5.0mm Screw Prep Upper Tray
• 00841132190975: 3P 5.0mm Screw Prep Lower Tray
• 00841132190968: 3P 5.0mm Screw Caddy
• 00841132190951: 3P 3.5mm Transphyseal Screw Caddy
• 00841132190944: 3P XL Screw Caddy
• 00841132190937: 3P 3.5mm Screw Prep Upper Tray
• 00841132190920: 3P 3.5mm Screw Prep Lower Tray
• 00841132190913: 3P 3.5mm Screw Caddy
• 00841132190906: 3P Beam - Trauma Upper Tray
• 00841132190890: 3P Beam - Trauma Lower Tray
• 00841132190883: 3P Beam - Child Trauma Caddy
• 00841132190876: 3P Beam - Transphyseal Caddy
• 00841132190869: 3P LPF - Upper Tray
• 00841132190791: 3P LPF - Lower Tray
• 00841132187654: 3P Adolescent Beam - Overlap Gauge 110°/120°, Wide
• 00841132187647: 3P Adolescent Beam - Overlap Gauge 90°/100°, Wide
• 00841132187616: 3P Adolescent Beam - Upper Tray
• 00841132187609: 3P Adolescent Beam - Lower Tray
• 00841132187593: 3P Adolescent Beam - Caddy
• 00841132187586: 3P Adolescent Beam - Overlap Gauge 110°/120°
• 00841132187579: 3P Child Beam - Upper Tray
• 00841132187562: 3P Child Beam - Lower Tray
• 00841132187555: 3P Child Beam - Caddy
• 00841132187548: 3P Child Beam - Overlap Gauge 110°/120°
• 00841132187531: 3P Infant Beam - Upper Tray
• 00841132187524: 3P Infant Beam - Lower Tray
• 00841132187517: 3P Infant Beam - Caddy
• 00841132187500: 3P Infant Beam - Overlap Gauge 110°/120°
• 00841132187494: Triangular Positioning Plate 110°/60°/10°
• 00841132187487: 3P Adolescent Bone Clamp
• 00841132187470: 3P Child Bone Clamp
• 00841132187463: Power Adaptor, ZH to 1/4" Square
• 00841132187456: Fixed Ball Handle, AO QC
• 00841132187449: Ratcheting Axial Handle, AO QC
• 00841132187432: Fixed T-Handle, ZH QC
• 00841132187425: Ratcheting T-Handle, ZH QC
• 00841132187418: 2.8mm x 250mm Smooth Guide Wire
• 00841132187401: 2.8mm x 250mm Threaded Guide Wire
• 00841132187395: 3.5mm/4.3mm Drill Depth Indicator
• 00841132187388: 2.5mm/2.8mm Drill Depth Indicator
• 00841132187159: 3P 3.5mm XL Calibrated Drill
• 00841132187142: 3P 2.5mm XL Calibrated Drill
• 00841132186718: 3P 4.5mm Cannulated Hex Driver
• 00841132186701: 3P Direct Measuring Device, 2.8mm x 250mm Wire
• 00841132186695: 3P T15 Retaining Driver, Long
• 00841132186688: 3P T20 Retaining Driver, Long
• 00841132186671: 3P 3.5mm Double Drill Guide
• 00841132186664: 3P 3.5mm Calibrated Drill
• 00841132186657: 3P 4.3mm Calibrated Drill