ATTUNE 299966465

GUDID 10603295511274

ATTUNE MAKE TO ORDER AP MODIFIED CUT BLOCK SIZE 8

DEPUY ORTHOPAEDICS, INC.

Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10603295511274
• NIH Device Record Key: b2693759-f6d9-4494-9783-2006d4ff2313
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATTUNE
• Version Model Number: 2999-66-465
• Catalog Number: 299966465
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295511274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140881

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

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

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

[10603295511274]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-08-12

On-Brand Devices [ATTUNE]

• 10603295493518: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 14mm
• 10603295493501: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 20mm
• 10603295493495: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 18mm
• 10603295493488: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 16mm
• 10603295493471: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 9 14mm
• 10603295493464: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 20mm
• 10603295493457: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 18mm
• 10603295493440: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 16mm
• 10603295493433: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 8 14mm
• 10603295493013: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 20mm
• 10603295493006: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 18mm
• 10603295492993: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIAL ROTATING PLATFORM POSTERIOR STABILIZED SIZE 10 16mm
• 10603295481638: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY PS RP SIZE 3-10, 14-20mm
• 10603295481607: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY RP SIZE 1-2, 5-18mm
• 10603295481577: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY PS FB SIZE 3-10, 14-20mm
• 10603295481553: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY CR SIZE 3-10, 14-16mm
• 10603295481546: ATTUNE KNEE SYSTEM TIBIAL INSERT TRIALS TRAY FB SIZE 1-2, 5-18mm
• 10603295484141: ATTUNE Make to Order Intuition Tibia Patella Preparation Sterilization Tray
• 10603295484134: ATTUNE Make to Order Intuition Primary Preparation Sterilization Tray
• 10603295455752: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZED INSERT TRIAL TRAY SIZE 3-8
• 10603295455745: ATTUNE MAKE TO ORDER FIXED BEARING CRUCIATE RETAINING INSERT TRIAL TRAY SIZE 3-8
• 10603295442066: ATTUNE MI TRAY
• 10603295494225: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 9, 3MM
• 10603295494218: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 8, 3MM
• 10603295494201: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 7, 3MM
• 10603295494195: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 6, 3MM
• 10603295494188: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 3, 3MM
• 10603295494171: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 10, 3MM
• 10603295494164: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 5, 3MM
• 10603295494157: ATTUNE MAKE TO ORDER Fixed Bearing Cruciate Retaining Tibial Insert Trial SIZE: 4, 3MM
• 10603295454120: MAKE TO ORDER ATTUNE FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 3 5MM
• 10603295454113: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 9
• 10603295454106: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 8
• 10603295454090: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 7
• 10603295454083: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 6
• 10603295454076: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 5
• 10603295454069: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 4
• 10603295454052: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 3
• 10603295454045: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 2
• 10603295454038: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 10
• 10603295454021: ATTUNE MAKE TO ORDER FEMORAL NOTCH TRIAL SIZE 1
• 10603295454014: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 8MM
• 10603295454007: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 7MM
• 10603295453994: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 6MM
• 10603295453987: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 5MM
• 10603295453970: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 12MM
• 10603295453963: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 8 10MM
• 10603295453956: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 7 8MM
• 10603295453949: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 7 7MM
• 10603295453932: ATTUNE MAKE TO ORDER FIXED BEARING POSTERIOR STABILIZING INSERT TRIAL SIZE 7 6MM