Identity
- Trade Name
- 2.8 TriLock OlecPl Dorsal Standard 11H,L EUDAMEDAPTUS FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Bone plates (sterile, non-sterile) EUDAMED2.8 TriLock OlecPl Dorsal Standard 11H,L FDA UDI
- Model / Reference
- A-4856.67S EUDAMEDFDA UDI
- Description
- 2.8 TriLock OlecPl Dorsal Standard 11H,L FDA UDI
Identifiers
- Catalog Number
- A-4856.67S FDA UDI
- Primary DI / UDI-DI
- 07630894812484 EUDAMEDFDA UDI
- Basic UDI-DI
- 76300378020P6 EUDAMED
- 510(k) Number
- K240613 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
Yes
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
Yes
Manufacturing Date
No
Category: Orthopaedic fixation plate, non-bioabsorbable
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.
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Cleared under the same submission
K240613 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 c5cf9a08-8c1f-4577-924b-722bf0c4be54 35 fields · synced Jul 24, 2026
- EUDAMED 10d0950a-bf42-4605-851b-7ba0b8626bb1 61 fields · synced Jul 24, 2026