Identity
- Trade Name
- 2.8 TriLock MTP Revis. Pl, 5° Dorsifl.,R EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED2.8 TriLock MTP Revis. Pl, 5° Dorsifl.,R FDA UDI
- Model / Reference
- A-4860.16 EUDAMEDFDA UDI
- Description
- 2.8 TriLock MTP Revis. Pl, 5° Dorsifl.,R FDA UDI
Identifiers
- Catalog Number
- A-4860.16 FDA UDI
- Primary DI / UDI-DI
- 07630037895862 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- 510(k) Number
- K142581 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Aptus by Medartis Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable, non-sterile.
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Cleared under the same submission
K142581 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medartis Inc.
Sources (2)
- FDA UDI 80c02ce0-ffd2-4cbc-abf4-07096a84af12 35 fields · synced Jul 12, 2026
- EUDAMED 353d5d5d-cc38-471e-9a7e-07794d642a00 61 fields · synced Jun 14, 2026