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FDA 510(k)

SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)

K-Number: K971408 · 1998-05-12

ApplicantIkonos Corp.
Decision Date1998-05-12
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) is the device name listed in this FDA 510(k) record. The listed applicant is Ikonos Corp.. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K971408. 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 SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)?

SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Ikonos Corp.. The 510(k) number is K971408.

When did SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) receive FDA 510(k) clearance?

SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) received FDA 510(k) clearance on 1998-05-12, under 510(k) number K971408.

Who is the listed applicant for SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)?

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

What is the FDA product code for SEVRAIN CRANIAL CLAMP (SCC-200 SERIES)?

The FDA product code for SEVRAIN CRANIAL CLAMP (SCC-200 SERIES) 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 Ikonos 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.

K971252SEVRAIN CRANIAL CLAMPK971454TYMPANOSTOMY VENTILATION TUBE

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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