| Primary Device ID | 07613327404944 | 
| NIH Device Record Key | e71e3864-20d4-4dd5-967e-7623fa9d8fe7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | INSTRUMENT | 
| Version Model Number | 6541-1-823Y | 
| Catalog Number | 6541-1-823Y | 
| 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 Size Text, specify | 0 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07613327404944 [Primary] | 
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
[07613327404944]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-11-10 | 
| Device Publish Date | 2023-11-02 | 
| 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 | 
| 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 |