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FDA 510(k)

OSTEOMED CRANIAL FLAP FIXATION SYSTEM

K-Number: K022277 · 2003-04-01

ApplicantOsteomed Corp.
Decision Date2003-04-01
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OSTEOMED CRANIAL FLAP FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteomed Corp.. It received FDA 510(k) clearance on 2003-04-01 under 510(k) number K022277. 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 OSTEOMED CRANIAL FLAP FIXATION SYSTEM?

OSTEOMED CRANIAL FLAP FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-01. The listed applicant is Osteomed Corp.. The 510(k) number is K022277.

When did OSTEOMED CRANIAL FLAP FIXATION SYSTEM receive FDA 510(k) clearance?

OSTEOMED CRANIAL FLAP FIXATION SYSTEM received FDA 510(k) clearance on 2003-04-01, under 510(k) number K022277.

Who is the listed applicant for OSTEOMED CRANIAL FLAP FIXATION SYSTEM?

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

What is the FDA product code for OSTEOMED CRANIAL FLAP FIXATION SYSTEM?

The FDA product code for OSTEOMED CRANIAL FLAP FIXATION SYSTEM is GXN.

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Other records listing Osteomed Corp. 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.

K022887INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK022886METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEMK0232601.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEMK013618INTRAORAL MANDIBULAR DISTRACTION SYSTEMK021618OSA RIGID INTERNAL FIXATION SYSTEMK012486OSTEOMED BIORESORBABLE FIXATION SYSTEM

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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.

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