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FDA 510(k)

DINKLER SURGICAL SKULL CLAMP, MODEL 0308

K-Number: K090695 · 2009-04-23

ApplicantDinkler Surgical Devices, Inc.
Decision Date2009-04-23
Product CodeHBL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DINKLER SURGICAL SKULL CLAMP, MODEL 0308 is the device name listed in this FDA 510(k) record. The listed applicant is Dinkler Surgical Devices, Inc.. It received FDA 510(k) clearance on 2009-04-23 under 510(k) number K090695. 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 DINKLER SURGICAL SKULL CLAMP, MODEL 0308?

DINKLER SURGICAL SKULL CLAMP, MODEL 0308 is a medical device that received FDA 510(k) clearance on 2009-04-23. The listed applicant is Dinkler Surgical Devices, Inc.. The 510(k) number is K090695.

When did DINKLER SURGICAL SKULL CLAMP, MODEL 0308 receive FDA 510(k) clearance?

DINKLER SURGICAL SKULL CLAMP, MODEL 0308 received FDA 510(k) clearance on 2009-04-23, under 510(k) number K090695.

Who is the listed applicant for DINKLER SURGICAL SKULL CLAMP, MODEL 0308?

The FDA 510(k) record lists Dinkler Surgical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DINKLER SURGICAL SKULL CLAMP, MODEL 0308?

The FDA product code for DINKLER SURGICAL SKULL CLAMP, MODEL 0308 is HBL.

Related Clinical Trials

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Other records listing Dinkler Surgical Devices, Inc. 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.

K073163LIMITED ARTIFACT SKULL PIN, MODEL 0107

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

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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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