ZipE Knotless Tissue Repair And Attachment Devices
ZIPTEK, LLC
ZIPTEK LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013722959 | 3013722959 | ZIPTEK LLC | 1 | N | 2026-01-01 | 1250 S TAMIAMI TRL STE 303 Sarasota FL US 34239 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 209463 | 1030956677 | K162429 | ZipE Knotless Tissue Repair and Attachment Devices | MAI | 2017-03-13 |
| 209463 | 1467344410 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MAI | 2 | 2017-03-13 |
PMN#
GUDID#
ZipE Knotless Tissue Repair and attachment devices - ZipE® resusable medical grade stainless steel punch tool
2024-07-19
Ziptek knotless tissue repair and attachment devices - Ziptek small driver/handle assembly medical grade stainless steel for 4.5mm screw insertion and for pushing capture/button
2024-07-19
Ziptek knotless tissue repair and attachment devices - Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr use with large 5.0mm screws and biocomposite plugs and as ZipE capture/button pusher
2024-07-19
ZipE Knotless Tissue Repair and Attachment Devices - Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4 , # 4 resorbable captures/capture holster, 2 #2 USP UHMWPE braided suture, two thermoplastic tip covers
2024-06-03
Zip E® Knotless Tissue Repair and Attachment Devices - Zip E® Knotless Tissue Repair and Attachment Devices- Rb41-S-4, #4 resorbable captures/ca[ture holster, 2 #2 USP UHMWPE braided sutures, two thermoplastic tip covers per kit- 6 kits per shipper ( 10858816006061
2024-06-03
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driverQty. 6
2019-06-04
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driverQty. 6
2019-06-04
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driverQty. 6
2019-06-04
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driverQty. 6
2019-06-04
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
2018-09-20
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver
2018-09-20
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices5.0 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
2018-09-20
ZipE® Knotless Tissue Repair and Attachment Devices - ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver
2018-09-20