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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, non-bioabsorbable FDA UDI
- Device Name
- ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver FDA UDI
- Model / Reference
- A6-6545-S FDA UDI
- Description
- ZipE® Knotless Tissue Repair and Attachment Devices - A6-6545-S 4.5 mm titanium screw, 6.5 resorbable capture, #2 braided suture, and driver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858816006033 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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, non-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, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
- FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
- Ecobone — Bonegraft Biomaterials Co. · Class III
- fX — Bonegraft Biomaterials Co. · Class III
- GII PANACRYL — DePuy Mitek, Inc. · Class II
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · 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 a8ab3cdd-d478-49b3-8709-23f1f1c2a314 33 fields · synced Jun 6, 2026