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spineEOS

FDA UDI

Class II (US FDA UDI)

by Onefit Medical

Identity

Trade Name
spineEOS FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
spineEOS 1.x 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.x FDA UDI
Description
spineEOS 1.x 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
03700757200858 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
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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic/craniofacial implantation planning software

spineEOS by Onefit Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Onefit Medical

Sources (1)

  • FDA UDI 4d846417-a30c-4e90-83aa-f945867713b5 35 fields · synced Jun 1, 2026