WasherCap™ Fixation System 9mm
GUDID 08437019739836
WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.
ABANZA TECNOMED SL.
Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable| Primary Device ID | 08437019739836 |
| NIH Device Record Key | b6cf56f0-8a2e-4b9a-b01c-c7097c8b22e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WasherCap™ Fixation System 9mm |
| Version Model Number | 21 |
| Company DUNS | 465714287 |
| Company Name | ABANZA TECNOMED SL. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com | |
| Phone | (866) 550-7070 |
| customerservice@abanzamed.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *This way up |
| Special Storage Condition, Specify | Between 0 and 0 *Fragile, handle with care |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08437019739836 [Primary] |
| GS1 | 28437019739830 [Package] Package: Secondary [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212197
FDA Product Code
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-19 |
| Device Publish Date | 2023-06-09 |
Devices Manufactured by ABANZA TECNOMED SL.
| 08437019739812 - WasherCap™ Fixation System 7mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739829 - WasherCap™ Fixation System 8mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739836 - WasherCap™ Fixation System 9mm | 2023-06-19WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee. |
| 08437019739836 - WasherCap™ Fixation System 9mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739843 - WasherCap™ Fixation System 10mm | 2023-06-19 WasherCap™ Fixation System is a device which provides soft tissue graft fastening. It is intended for fixation of soft tissue |
| 08437019739164 - WasherCap™ Screwdriver | 2023-06-09 Instrument used to screw the “screw-washer” assembly to the cap, locking the tendon against the locking corridor of the cap. |
| 08437019739317 - Sterilization tray | 2023-06-09 Tray supplied with the set containing the above-mentioned instruments, fixed by silicon fasteners. The tray is used to transport |
| 08437019739324 - Handle with AO connection system | 2023-06-09 Accessory handle used to insert instruments with AO connection. |
| 08437019739331 - Countersink tool | 2023-06-09 Tool used to thread and unscrew the top of the countersink body for easy disassembly. |
Trademark Results [WasherCap]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 WASHERCAP 98047014 not registered Live/Pending |
Abanza Tecnomed, S.L. 2023-06-16 |
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