Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsSurgical navigation instruments
Surgical navigation system
EMDN code Z12011401
Manufacturers registered in Europe (EUDAMED) 31
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 4
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Neocis, Inc. | United States | Neocis Guidance System YomiLink Arch (LLUR) Yomi S YomiLink Arch LLUR YLB-IOFA- Large Yomi S Extra Oral Fiducial Array LRUL YomiLink Bone (LR) | K261321 (2026) |
| Navigate Surgical Technologies Inc | Canada | Inliant | K213392 (2022) |
| Nobel Biocare Services AG Present in Europe in other categories | Switzerland | – | registered |
| PACIFIC PLASTICS INJECTION MOLDING | United States | – | registered |
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Related categories
- Surgical navigation instruments - hardware accessories27 manufacturers
- Surgical navigation instruments - consumables24 manufacturers
- Surgical navigation instruments - software accessories10 manufacturers
- Surgical navigation instruments - medical device software9 manufacturers
- Parent category : Surgical navigation instruments31 manufacturers