Identity
- Trade Name
- spineEOS FDA UDI
- Generic Name
- Orthopaedic/craniofacial implantation planning software FDA UDI
- Device Name
- spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. FDA UDI
- Model / Reference
- 1.1 FDA UDI
- Description
- spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03700757200544 FDA UDI
- 510(k) Number
- K160407 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Orthopaedic/craniofacial implantation planning software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
spineEOS by Onefit Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K160407 also covers:
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
- Onefit Medical
Sources (1)
- FDA UDI 3130167f-4a1e-4766-9fe9-71669d1e597e 36 fields · synced Jun 1, 2026