INSTRUMENT I-K2859BP02

GUDID 07613327329759

SPECIALTY TRIATHLON TIBIAL TEMPLATE w POSTERIOR FEET NO. 2

Howmedica Osteonics Corp.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 07613327329759
• NIH Device Record Key: 27ecc566-142c-423f-9867-25413cad7d91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSTRUMENT
• Version Model Number: I-K2859BP02
• Catalog Number: I-K2859BP02
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327329759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173849

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

Moist Heat or Steam Sterilization

[07613327329759]

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: 2019-12-20

On-Brand Devices [INSTRUMENT]

• 00848486028039: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486028022: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486028015: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486028008: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027995: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027988: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027971: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027964: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027957: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027940: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027933: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027926: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027919: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027902: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027896: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027889: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027872: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027865: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027858: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027841: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027834: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027827: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 00848486027810: CUTTING EDGE ACETABULAR SPHERICAL REAMER
• 07613327462906: TRIATHLON SOLID TIBIAL INSERT TRIAL-PS
• 07613327460636: SPECIALTY MRS ELBOW IMPACTOR/EXTRACTOR
• 07613327459609: Specialty Universal 3.5mm Hex Driver
• 07613327455816: SPECIALTY TRIATHLON PATELLA CEMENT CAP WITH COVER
• 07613327425741: Specialty Triathlon 3 Degree Tibial Recut Guide Right
• 07613327425727: Specialty Triathlon 3 Degree Tibial Recut Guide Left
• 07613327425390: Specialty Triathlon MIS Femoral Stylus with Spacer
• 07613327424201: Specialty Triathlon Metal Backed Patella Protector S/M
• 07613327424195: Specialty Triathlon Metal Backed Patella Protector M/L
• 07613327424034: Specialty Triathlon Femoral Alignment Guide
• 07613327423792: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 16MM
• 07613327423785: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 15MM
• 07613327423778: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 17MM
• 07613327423761: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 19MM
• 07613327423754: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 13MM
• 07613327423747: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 11MM
• 07613327423730: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 20MM
• 07613327423723: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 14MM
• 07613327423716: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 18MM
• 07613327423709: PRIM. SECUR-FIT PLUS CYLIN. DISTAL EXTEN-SIZE 12MM
• 07613327419795: Specialty Triathlon Tibial Symmetric Cone Reamer Size A
• 07613327419771: Specialty Triathlon Tibial Symmetric Cone Reamer Size C
• 07613327419764: Specialty Triathlon Tibial Symmetric Cone Reamer Size B
• 07613327419757: Specialty Triathlon Tibial Symmetric Cone Reamer Size D
• 07613327418972: Specialty Monogram Pistol Clamp Assembly
• 07613327418965: Specialty Monogram Patella Outrigger for Xcelerate Cutters
• 07613327418347: SPECIALTY XCELERATE PATELLA CLAMPING BARREL 42MM