| Primary Device ID | 10886705002986 |
| NIH Device Record Key | 1b535d4e-529b-4de8-b4b7-0709c74b92d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIGIDFIX |
| Version Model Number | 213704 |
| Catalog Number | 213704 |
| Company DUNS | 190572854 |
| Company Name | DEPUY MITEK, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705002986 [Primary] |
| GEF | APPLIER, STAPLE, SURGICAL, |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
[10886705002986]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2015-09-01 |
| 20886705020017 | RIGIDFIX CURVE ST ACL PEEK Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm PEEK, (2) each |
| 20886705020000 | RIGIDFIX CURVE ST ACL PLA Cross Pin System (2) each ST Cross Pins, 3.3mm x 42mm Poly Lactic Acid |
| 10886705002986 | RIGIDFIX Femoral Step Pin Insertion Rod |
| 10886705002665 | RIGIDFIX TIBIAL PIN INSERTION ROD |
| 10886705023394 | RIGIDFIX CURVE Cross Pin System Ancillary Instrumentation Tray |
| 10886705023387 | RIGIDFIX CURVE Cross Pin System Instrumentation Tray |
| 10886705004874 | Combo RIGIFIX Caddy |
| 10886705004867 | BTB RIGIDFIX Caddy |
| 10886705004850 | S T RIGIDFIX Caddy |
| 10886705004843 | RIGIDFIX Sterilization Tray |
| 10886705003358 | RIGIDFIX TIBIAL ROD 9.5mm, 20-90mm (Plus or Minus 5 Percent) |
| 10886705003334 | RIGIDFIX TIBIAL ROD Soft Tissue Only 7.5mm, 20-90mm (Plus or Minus 5 Percent) |
| 10886705003259 | RIGIDFIX TIBIAL ROD Bone Tendon Bone Only 12mm, 20-90mm (Plus or Minus 5 Percent) |
| 10886705003242 | RIGIDFIX TIBIAL ROD Bone Tendon Bone Only 11mm, 20-90mm (Plus or Minus 5 Percent) |
| 10886705003235 | RIGIDFIX TIBIAL ROD 10mm, 20-90mm (Plus or Minus 5 Percent) |
| 10886705003211 | RIGIDFIX TIBIAL ROD Soft Tissue Only 8mm, 20-90mm (Plus or Minus 5 Percent) |
| 10886705003204 | RIGIDFIX TIBIAL ROD Soft Tissue Only 7mm, 20-90mm (Plus or Minus 5 Percent) |
| 10886705003174 | RIGIDFIX TIBIAL BTB STEP TROCAR, SHORT |
| 10886705003150 | RIGIDFIX TIBIAL BTB GUIDE BLOCK |
| 10886705003143 | RIGIDFIX TIBIAL ST GUIDE BLOCK |
| 10886705003136 | RIGIDFIX Tibial Guide Frame 40-90mm (Plus or Minus 10 Percent) |
| 10886705002948 | RIGIDFIX ST Tibial Plateau Rod 9.5mm |
| 10886705002931 | RIGIDFIX ST Tibial Plateau Rod 8.5mm |
| 10886705002924 | RIGIDFIX ST Tibial Plateau Rod 7.5mm |
| 10886705002900 | RIGIDFIX Tibial Locking Ring 9.5mm |
| 10886705002894 | RIGIDFIX Tibial Locking Ring 8.5mm |
| 10886705002887 | RIGIDFIX Tibial Locking Ring 7.5mm |
| 10886705002863 | RIGIDFIX Tibial Trocar/Sleeve Trial |
| 10886705002801 | RIGIDFIX Tibial Locking Ring 10mm |
| 10886705002795 | RIGIDFIX Tibial Locking Ring 9mm |
| 10886705002788 | RIGIDFIX Tibial Locking Ring 8mm |
| 10886705002771 | RIGIDFIX Tibial Locking Ring 7mm |
| 10886705002726 | RIGIDFIX ST Tibial Plateau Rod 10mm |
| 10886705002719 | RIGIDFIX ST Tibial Plateau Rod 9mm |
| 10886705002702 | RIGIDFIX ST Tibial Plateau Rod 8mm |
| 10886705002696 | RIGIDFIX ST Tibial Plateau Rod 7mm |
| 10886705002641 | RIGIDFIX ST Tibial Plateau Guide Frame |
| 10886705020164 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 11 mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020157 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 10.5mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020140 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 10 mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020133 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 9.5 mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020126 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 9mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020119 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 8.5mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020102 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 8mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020096 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 7.5mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020089 | RIGIDFIX CURVE Femoral Rod Soft Tissue Only 7mm, 30-110mm (Plus or Minus 6 Percent) |
| 10886705020072 | RIGIDFIX CURVE Cross Pin System FEMORAL ROD, Soft Tissue Only 6.5mm, 30-110mm (Plus or Minus 6 P |
| 10886705020065 | RIGIDFIX CURVE Cross Pin System FEMORAL ROD, Soft Tissue Only 6mm, 30-110mm (Plus or Minus 6 Per |
| 10886705019977 | RIGIDFIX CURVE ST Guide Block ST Guide Block |
| 10886705019960 | RIGIDFIX CURVE Arc Attachment Arc Attachment |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RIGIDFIX 75668032 2394288 Live/Registered |
JOHNSON & JOHNSON 1999-03-26 |
![]() RIGIDFIX 75607084 not registered Dead/Abandoned |
Johnson & Johnson 1998-12-17 |