RIGIDFIX 210133
GUDID 10886705000890
RIGIDFIX FEMORAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm Poly Lactic Acid (PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar
Medos International Sàrl
Tendon/ligament bone anchor, bioabsorbable| Primary Device ID | 10886705000890 |
| NIH Device Record Key | 4566b8bb-f1c8-446c-839e-be387203a03e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RIGIDFIX |
| Version Model Number | 210133 |
| Catalog Number | 210133 |
| Company DUNS | 482661753 |
| Company Name | Medos International Sàrl |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| 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 | |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 and 26 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 and 26 Degrees Celsius |
| Storage Environment Temperature | Between 0 and 80 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886705000890 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974341
FDA Product Code
| HTY | PIN, FIXATION, SMOOTH |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2024-01-09 |
| Device Publish Date | 2015-09-01 |
On-Brand Devices [RIGIDFIX]
| 10886705019991 | RIGIDFIX CURVE Sterilization Tray |
| 10886705000890 | RIGIDFIX FEMORAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm Poly Lactic Acid (PLA), ( |
| 10886705000883 | RIGIDFIX BTB CROSS PIN KIT (2) each BTB CROSS PINS, 2.7mm x 42mm Poly Lactic Acid (PLA), (2) eac |
| 10886705002993 | RIGIDFIX Mallet |
| 10886705002634 | RIGIDFIX Femoral/Tibial Rod Thumb Screw |
Trademark Results [RIGIDFIX]
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 |
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