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FDA 510(k)

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT

K-Number: K121102 · 2012-08-08

ApplicantOsteosymbionics, LLC
Decision Date2012-08-08
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Osteosymbionics, LLC. It received FDA 510(k) clearance on 2012-08-08 under 510(k) number K121102. 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 OSTEOSYMBIONICS PEEK CRANIAL IMPLANT?

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT is a medical device that received FDA 510(k) clearance on 2012-08-08. The listed applicant is Osteosymbionics, LLC. The 510(k) number is K121102.

When did OSTEOSYMBIONICS PEEK CRANIAL IMPLANT receive FDA 510(k) clearance?

OSTEOSYMBIONICS PEEK CRANIAL IMPLANT received FDA 510(k) clearance on 2012-08-08, under 510(k) number K121102.

Who is the listed applicant for OSTEOSYMBIONICS PEEK CRANIAL IMPLANT?

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

What is the FDA product code for OSTEOSYMBIONICS PEEK CRANIAL IMPLANT?

The FDA product code for OSTEOSYMBIONICS PEEK CRANIAL IMPLANT 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.

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Other records listing Osteosymbionics, LLC 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.

K111069OSTEOSYMBIONICS, ST TEMPORALIS IMPLANTK072601OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT

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

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

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