Identity
- Trade Name
- BIOKNOTLESS PANACRYL ETHIBOND FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- BIOKNOTLESS BR Anchor w/PANACRYL TCP/PLGA Absorbable Anchor, Size 1 (4 metric) PANACRYL braided absorbable suture anchor loop, Size 2/0 green ETHIBOND polyester non-absorbable suture utility loop. FDA UDI
- Model / Reference
- 212723 FDA UDI
- Description
- BIOKNOTLESS BR Anchor w/PANACRYL TCP/PLGA Absorbable Anchor, Size 1 (4 metric) PANACRYL braided absorbable suture anchor loop, Size 2/0 green ETHIBOND polyester non-absorbable suture utility loop. FDA UDI
Identifiers
- Catalog Number
- 212723 FDA UDI
- Primary DI / UDI-DI
- 10886705002092 FDA UDI
- FDA Product Code
- GAS FDA UDIGAT FDA UDIGAM FDA UDIMAI FDA UDIJDR FDA UDIMBI FDA UDIHTY FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI878.4493 FDA UDI888.3030 FDA UDI888.3040 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
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
Bioknotless Panacryl 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
K040827 also covers:
K070925 also covers:
K150209 also covers:
- BIOKNOTLESS 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.
- MILAGRO — DePuy Mitek, Inc.
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
- DePuy Mitek, Inc.
Sources (1)
- FDA UDI 561a9bf2-aa67-4062-aed9-f0cec74a5770 37 fields · synced May 30, 2026