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ZipE® Knotless Tissue Repair and Attachment Devices
FDA UDIClass II (US FDA UDI)
by Ziptek, LLC
Identity
- Trade Name
- ZipE® Knotless Tissue Repair and Attachment Devices FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6 FDA UDI
- Model / Reference
- RA6-6565-S FDA UDI
- Description
- ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6565-S 6.5 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driver Qty. 6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10858816006016 FDA UDI
- FDA Product Code
- MAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbable
ZipE® Knotless Tissue Repair and Attachment Devices by Ziptek, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, bioabsorbable.
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- HEALIX PEEK ORTHOCORD — Medos International Sàrl · Class II
- Arthrex® — Arthrex, Inc. · Class II
- 5 x 15mm CitreLock Implant — ACUITIVE TECHNOLOGIES · Class II
- Fix2Lock — OSTEONIC CO., Ltd. · Class II
- Fixone Hybrid Anchor — AJU PHARM. CO., LTD. · Class II
- RIGIDFIX BIOCRYL — Medos International Sàrl · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ziptek, LLC
Sources (1)
- FDA UDI 54cf5b13-414e-40b8-834c-c28595eed2a8 33 fields · synced Jun 8, 2026