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FDA 510(k)

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

K-Number: K163156 · 2017-01-18

ApplicantMaterialise NV
Decision Date2017-01-18
Product CodePBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2017-01-18 under approval number K163156. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides?

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides is a medical device that received FDA 510(k) clearance on 2017-01-18. It is manufactured by Materialise NV. The 510(k) number is K163156.

When was SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides approved by the FDA?

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides received FDA 510(k) clearance on 2017-01-18, under approval number K163156.

What company makes SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides?

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides is manufactured by Materialise NV.

What is the FDA product code for SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides?

The FDA product code for SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides is PBF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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