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FDA 510(k)

STRYKER TWIST DRILLS

K-Number: K070876 · 2007-04-27

ApplicantStryker Craniomaxillofacial
Decision Date2007-04-27
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STRYKER TWIST DRILLS is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Craniomaxillofacial. It received FDA 510(k) clearance on 2007-04-27 under 510(k) number K070876. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER TWIST DRILLS?

STRYKER TWIST DRILLS is a medical device that received FDA 510(k) clearance on 2007-04-27. The listed applicant is Stryker Craniomaxillofacial. The 510(k) number is K070876.

When did STRYKER TWIST DRILLS receive FDA 510(k) clearance?

STRYKER TWIST DRILLS received FDA 510(k) clearance on 2007-04-27, under 510(k) number K070876.

Who is the listed applicant for STRYKER TWIST DRILLS?

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

What is the FDA product code for STRYKER TWIST DRILLS?

The FDA product code for STRYKER TWIST DRILLS is HBE.

Related Clinical Trials

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Other records listing Stryker Craniomaxillofacial 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.

K232350Stryker Facial iD SystemK092743THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM

Related Devices (Code: HBE)

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.

K253627Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2)Surgify Medical OYK250815Hubly Drill (H100)Hubly, Inc.K252060GREENPhasor Health, LLCK252662UniBurNakanishi, Inc.K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)Surgify Medical OYK250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)Surgify Medical OY

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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