Identity
- Trade Name
- PANALOK ETHIBOND FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter. FDA UDI
- Model / Reference
- 210025 FDA UDI
- Description
- PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter. FDA UDI
Identifiers
- Catalog Number
- 210025 FDA UDI
- Primary DI / UDI-DI
- 10886705000807 FDA UDI
- FDA Product Code
- MAI FDA UDIMBI FDA UDIHRX FDA UDIJDR FDA UDIHTY FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI888.1100 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
No
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
No
FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbable
Panalok Ethibond by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tendon/ligament bone anchor, bioabsorbable.
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Cleared under the same submission
K150209 also covers:
- BIOKNOTLESS ETHIBOND — DePuy Mitek, Inc.
- BIOKNOTLESS PANACRYL ETHIBOND — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- INTRAFIX — DePuy Mitek, Inc.
- LUPINE — DePuy Mitek, Inc.
- LUPINE — DePuy Mitek, Inc.
- LUPINE ETHIBOND — DePuy Mitek, Inc.
- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
K952687 also covers:
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
- Manufacturer
- DePuy Mitek, Inc.
Sources (1)
- FDA UDI 4657c2b1-7881-4259-b170-0fd9c7bb8edc 38 fields · synced May 30, 2026