Identity
- Trade Name
- Mako FDA UDI
- Generic Name
- Orthopaedic bur, single-use FDA UDI
- Device Name
- TD-03 - MAKO - Class IIa - Reamers and Burs - Metal EUDAMEDMAKO SHOULDER ROUTER FDA UDI
- Model / Reference
- 190671 EUDAMEDFDA UDI08858251002251SD EUDAMED
- Description
- MAKO SHOULDER ROUTER FDA UDI
Identifiers
- Catalog Number
- 190671 FDA UDI
- Primary DI / UDI-DI
- 07613327627220 EUDAMEDFDA UDI
- Basic UDI-DI
- 08858251002251SD EUDAMED
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bur, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic bur, single-use
Mako by MAKO Surgical Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- MAKO Surgical Corp.
Sources (2)
- FDA UDI 0101705e-5ab0-4ad1-a0db-4df653ea77a8 34 fields · synced Jun 11, 2026
- EUDAMED fabe161e-2efb-4057-8f07-91f1e97fd4d1 61 fields · synced Jun 11, 2026