← Back to catalogue
Betta Link Knotless Long - Implant Kit
FDA UDIClass II (US FDA UDI)
by T.a.g Medical Products Agricultural Cooperative Association
Identity
- Trade Name
- Betta Link Knotless Long - Implant Kit FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Model / Reference
- 110045160 FDA UDI
Identifiers
- Catalog Number
- 180200bsm FDA UDI
- Primary DI / UDI-DI
- 10818674028827 FDA UDI
- 510(k) Number
- K210498 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
No
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
Betta Link Knotless Long - Implant Kit by T.a.g Medical Products Agricultural Cooperative Association — Class II — FDA UDI — listed in FDA GUDID
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
Cleared under the same submission
K210498 also covers:
- Betta Link Knotless - Implant Kit — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Betta Link Knotless - Implant Only — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Betta Link Knotless Long - Implant Only — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Betta Link LG Knotless Hip IMPLANT ONLY — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Betta Link LG Knotless Hip Implant KIT — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Betta Link SR Knotless Shoulder IMPLANT ONLY — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- Betta Link SR Knotless Shoulder Implant KIT — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI e4e23738-9130-41d5-8953-00f3ba643058 34 fields · synced May 30, 2026