Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k) K251532 · Mighty Oak Medical
510(k) numberK251532
Submission
- Device name
- Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
- Applicant
- Mighty Oak Medical
Englewood, CO, US - Received
- May 19, 2025
- Decision date
- November 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262143 | ImageGrid StreamVueLLZ · Traditional | Candelis, Inc. | 07/23/2026SE |
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More from Avara Software
| 510(k) | Device | Decision |
|---|---|---|
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 06/11/2026SE |
| K253472 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 02/25/2026SE |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 12/02/2025SE |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 07/12/2024SE |
| K220132 | FIREFLY® Cervical Navigation GuideQSD · Traditional | 10/26/2022SE |
| K181883 | FIREFLY® Midline Navigation GuidePQC · Traditional | 10/03/2018SE |
| K181399 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 07/24/2018SE |
| K162419 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 10/28/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | 12/11/2015SE |
Questions and answers
When was Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) cleared by the FDA?
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (K251532) received a 510(k) decision of Substantially Equivalent on November 3, 2025, 168 days after the submission was received.
What is the product code of K251532?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.