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FDA 510(k)

MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS

K-Number: K071458 · 2007-06-13

ApplicantIntegra LifeSciences Corporation
Decision Date2007-06-13
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS is the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2007-06-13 under 510(k) number K071458. 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 MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS?

MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS is a medical device that received FDA 510(k) clearance on 2007-06-13. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K071458.

When did MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS receive FDA 510(k) clearance?

MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS received FDA 510(k) clearance on 2007-06-13, under 510(k) number K071458.

Who is the listed applicant for MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS?

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

What is the FDA product code for MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS?

The FDA product code for MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS is HBL.

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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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