SOLUTION SYSTEM 125735000

GUDID 10603295019886

SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 35mm

DEPUY ORTHOPAEDICS, INC.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 10603295019886
• NIH Device Record Key: e2ea07ff-662a-4716-9ccd-b9dcb3bd7fc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOLUTION SYSTEM
• Version Model Number: 1257-35-000
• Catalog Number: 125735000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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(800)255-2500
• Email: xx@xx.xx
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295019886 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861979

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-10-27
• Device Publish Date: 2015-09-24

On-Brand Devices [SOLUTION SYSTEM]

• 10603295148982: SOLUTION SYSTEM FEMORAL INSTRUMENT CASE
• 10603295148975: SOLUTION SYSTEM BOTTOM TRAY - FEMUR
• 10603295148968: SOLUTION SYSTEM TOP TRAY - FEMUR
• 10603295148951: SOLUTION SYSTEM INSTRUMENT TRAY COMPLETE
• 10603295148944: SOLUTION SYSTEM 8/10 IN BOW KIT COMPLETE
• 10603295148906: SOLUTION SYSTEM TRIAL TRAY CALCARS 7 & 9IN
• 10603295148890: SOLUTION SYSTEM 8 IN STRAIGHT KIT COMPLETE
• 10603295148876: SOLUTION SYSTEM TRIAL TRAY 10 IN L/R
• 10603295148869: SOLUTION SYSTEM TRIAL TRAY 8 IN L/R
• 10603295148852: SOLUTION SYSTEM TRIAL TRAY STRAIGHT 8 IN
• 10603295086925: SOLUTION SYSTEM RETRACTOR FIX PINS
• 10603295019947: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 65mm
• 10603295019930: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 60mm
• 10603295019923: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 55mm
• 10603295019916: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 50mm
• 10603295019909: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 45mm
• 10603295019893: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 40mm
• 10603295019886: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 35mm
• 10603295019879: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 30mm
• 10603295019862: SOLUTION SYSTEM PERIPHERAL BONE SCREW 5.0mm x 25mm
• 10603295062110: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT RIGHT 9 Inches 22.5mm
• 10603295062103: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT RIGHT 9 Inches 21.0mm
• 10603295062097: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT RIGHT 9 Inches 19.5mm
• 10603295062080: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT RIGHT 9 Inches 18.0mm
• 10603295062073: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT RIGHT 9 Inches 16.5mm
• 10603295062066: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT RIGHT 9 Inches 15.0mm
• 10603295062059: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT RIGHT 9 Inches 13.5mm
• 10603295062042: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT LEFT 9 Inches 22.5mm
• 10603295062035: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT LEFT 9 Inches 21.0mm
• 10603295062028: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT LEFT 9 Inches 19.5mm
• 10603295062011: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT LEFT 9 Inches 18.0mm
• 10603295062004: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT LEFT 9 Inches 16.5mm
• 10603295061991: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT LEFT 9 Inches 15.0mm
• 10603295061984: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER CALCAR STEM POROCOAT LEFT 9 Inches 13.5mm
• 10603295061717: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE RIGHT 10 Inches 13.5mm
• 10603295061687: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE LEFT 10 Inches 19.5mm
• 10603295061625: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE RIGHT 8 Inches 21.0mm
• 10603295061601: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER BOWED LARGE STATURE RIGHT 8 Inches 18.0mm
• 10603295061496: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT LARGE STATURE 8 Inches 22.5mm 45m
• 10603295061489: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT LARGE STATURE 8 Inches 21.0mm 45m
• 10603295061472: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT LARGE STATURE 8 Inches 19.5mm 45m
• 10603295061465: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT LARGE STATURE 8 Inches 18.0mm 45m
• 10603295061458: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT LARGE STATURE 8 Inches 16.5mm 45m
• 10603295061441: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT LARGE STATURE 8 Inches 15.0mm 45m
• 10603295061403: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT SMALL STATURE 8 Inches 22.5mm 43m
• 10603295061397: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT SMALL STATURE 8 Inches 21.0mm 43m
• 10603295061380: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT SMALL STATURE 8 Inches 19.5mm 43m
• 10603295061373: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT SMALL STATURE 8 Inches 18.0mm 43m
• 10603295061366: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT SMALL STATURE 8 Inches 16.5mm 43m
• 10603295061359: SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER STRAIGHT SMALL STATURE 8 Inches 15.0mm 43m