FDA 510(k)

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides

K-Number: K163156 · 2017-01-18

Decision Date2017-01-18

Product CodePBF

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2017-01-18 under 510(k) 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. The listed applicant is Materialise NV. The 510(k) number is K163156.

When did SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides receive FDA 510(k) clearance?

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

Who is the listed applicant for SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase Guides?

The FDA 510(k) record lists Materialise NV as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Materialise NV as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K251964Mimics Thoracic Planner K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models K253793Materialise TKA Guide System K251554Materialise TKA Guide System K243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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Official Source

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