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FDA 510(k)

FIXIT HEADREST CLAMP SYSTEM

K-Number: K083803 · 2010-03-10

ApplicantMedicon EG
Decision Date2010-03-10
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FIXIT HEADREST CLAMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicon EG. It received FDA 510(k) clearance on 2010-03-10 under 510(k) number K083803. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXIT HEADREST CLAMP SYSTEM?

FIXIT HEADREST CLAMP SYSTEM is a medical device that received FDA 510(k) clearance on 2010-03-10. The listed applicant is Medicon EG. The 510(k) number is K083803.

When did FIXIT HEADREST CLAMP SYSTEM receive FDA 510(k) clearance?

FIXIT HEADREST CLAMP SYSTEM received FDA 510(k) clearance on 2010-03-10, under 510(k) number K083803.

Who is the listed applicant for FIXIT HEADREST CLAMP SYSTEM?

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

What is the FDA product code for FIXIT HEADREST CLAMP SYSTEM?

The FDA product code for FIXIT HEADREST CLAMP SYSTEM is HBL.

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Other records listing Medicon EG 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.

K161680MEDICON Spinal Spreading SystemsK100916MEDICON MOGEN CLAMPK053624MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEMK050478MEDICON IMF-ORION SCREWSK043297MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEMK042974MEDICON VIPAIR HIGH SPEED SYSTEM

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Related Devices (Code: HBL)

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.

K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbHK241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbHK240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbHK203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbHK193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbHK191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH

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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