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)

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE

K-Number: K121818 · 2013-02-07

ApplicantOxford Performance Materials
Decision Date2013-02-07
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Performance Materials. It received FDA 510(k) clearance on 2013-02-07 under 510(k) number K121818. 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 OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE?

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE is a medical device that received FDA 510(k) clearance on 2013-02-07. The listed applicant is Oxford Performance Materials. The 510(k) number is K121818.

When did OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE receive FDA 510(k) clearance?

OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE received FDA 510(k) clearance on 2013-02-07, under 510(k) number K121818.

Who is the listed applicant for OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE?

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

What is the FDA product code for OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE?

The FDA product code for OSTEOFAB PATIENT SPECIFIC CRANIAL DEVICE is GXN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

↑