Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CustomizedBone Service

K-Number: K160707 · 2016-12-17

ApplicantFin-Ceramica Faenza S.P.A.
Decision Date2016-12-17
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CustomizedBone Service is the device name listed in this FDA 510(k) record. The listed applicant is Fin-Ceramica Faenza S.P.A.. It received FDA 510(k) clearance on 2016-12-17 under 510(k) number K160707. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CustomizedBone Service?

CustomizedBone Service is a medical device that received FDA 510(k) clearance on 2016-12-17. The listed applicant is Fin-Ceramica Faenza S.P.A.. The 510(k) number is K160707.

When did CustomizedBone Service receive FDA 510(k) clearance?

CustomizedBone Service received FDA 510(k) clearance on 2016-12-17, under 510(k) number K160707.

Who is the listed applicant for CustomizedBone Service?

The FDA 510(k) record lists Fin-Ceramica Faenza S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CustomizedBone Service?

The FDA product code for CustomizedBone Service is GXN.

Other records listing Fin-Ceramica Faenza S.P.A. 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.

K240567CustomizedBone ServiceK193547CustomizedBone ServiceK180513CustomizedBone ServiceK171507CustomizedBone Service

Related Devices (Code: GXN)

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.

K260709ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)Longeviti Neuro SolutionsK2531163D MAC Titanium Cranial Plate (TCP) SystemThe Surgeon General, Department of the Army (TSG-DA)K252251EASYMADE-TICG Bio Co., Ltd.K252958METICULY Patient-specific titanium mesh implantMeticuly Co., Ltd.K243715Synthes Patient Specific ImplantsSynthes GmbHK252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILEKLS-Martin L.P.

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.

↑