Identity
- Trade Name
- RIGIDFIX BIOCRYL FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Device Name
- RIGIDFIX BIOCRYL TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar FDA UDI
- Model / Reference
- 210817 FDA UDI
- Description
- RIGIDFIX BIOCRYL TIBIAL ST CROSS PIN KIT (2) each ST Cross Pins, 3.3mm x 42mm BIOCRYL (TCP/PLA), (2) each Sleeve Assemblies, and (1) each Interlocking Trocar FDA UDI
Identifiers
- Catalog Number
- 210817 FDA UDI
- Primary DI / UDI-DI
- 10886705001316 FDA UDI
- FDA Product Code
- HWC FDA UDIMAI FDA UDIHTY FDA UDIJDR FDA UDIMBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
No
FDA UDI
Category: Tendon/ligament bone anchor, bioabsorbable
Rigidfix Biocryl by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, bioabsorbable.
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- Fixone Hybrid Anchor — AJU PHARM. CO., LTD. · Class II
- RIGIDFIX BIOCRYL — Medos International Sàrl · Class II
Cleared under the same submission
K090669 also covers:
K091041 also covers:
K150209 also covers:
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- 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.
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 5a08aa33-7762-4278-9ed2-49da64444799 38 fields · synced May 30, 2026