Identity
- Trade Name
- MILAGRO FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLGA 9 x 23mm FDA UDI
- Model / Reference
- 231820 FDA UDI
- Description
- MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLGA 9 x 23mm FDA UDI
Identifiers
- Catalog Number
- 231820 FDA UDI
- Primary DI / UDI-DI
- 10886705010790 FDA UDI
- FDA Product Code
- MAI FDA UDIHWC FDA UDIJDR FDA UDIHTY FDA UDIMBI FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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: Bioabsorbable orthopaedic bone screw
Milagro by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioabsorbable orthopaedic bone screw.
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- Arthrex® — Arthrex, Inc. · Class II
- MILAGRO — Medos International Sàrl · Class II
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K032717 also covers:
K060830 also covers:
K150209 also covers:
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- MICROFIX QUICKANCHOR ETHIBOND — DePuy Mitek, Inc.
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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 f56f3d3b-1964-4c86-9fd2-186989c9c87c 36 fields · synced May 30, 2026