INSTRUMENT 5532-T-216Y
GUDID 07613327402322
TRIATHLON SOLID TIBIAL INSERT TRIAL-PS
Howmedica Osteonics Corp.
Knee tibia prosthesis trial| Primary Device ID | 07613327402322 |
| NIH Device Record Key | 97436a5f-3026-4f6f-b18a-81a56c518b87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INSTRUMENT |
| Version Model Number | 5532-T-216Y |
| Catalog Number | 5532-T-216Y |
| Company DUNS | 058311945 |
| Company Name | Howmedica Osteonics Corp. |
| Device Count | 1 |
| DM Exempt | true |
| 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 Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327402322 [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 |
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
[07613327402322]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2018-12-21 |
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 |
Trademark Results [INSTRUMENT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INSTRUMENT 86648787 not registered Dead/Abandoned |
Wright, Bruce David 2015-06-02 |
 INSTRUMENT 86251255 4640905 Live/Registered |
INSTRUMENT LLC 2014-04-14 |
 INSTRUMENT 85068560 not registered Dead/Abandoned |
Instrument Skateboards LLC 2010-06-22 |
 INSTRUMENT 77742928 3725465 Dead/Cancelled |
Instrument Marketing, Inc. 2009-05-22 |
 INSTRUMENT 74508227 not registered Dead/Abandoned |
Pro Golf of America, Inc. 1994-04-04 |
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