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FDA 510(k)

CRANIOTOME BLADE OR DRILL BIT

K-Number: K902703 · 1990-11-13

ApplicantA. Henniss
Decision Date1990-11-13
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANIOTOME BLADE OR DRILL BIT is the device name listed in this FDA 510(k) record. The listed applicant is A. Henniss. It received FDA 510(k) clearance on 1990-11-13 under 510(k) number K902703. 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 CRANIOTOME BLADE OR DRILL BIT?

CRANIOTOME BLADE OR DRILL BIT is a medical device that received FDA 510(k) clearance on 1990-11-13. The listed applicant is A. Henniss. The 510(k) number is K902703.

When did CRANIOTOME BLADE OR DRILL BIT receive FDA 510(k) clearance?

CRANIOTOME BLADE OR DRILL BIT received FDA 510(k) clearance on 1990-11-13, under 510(k) number K902703.

Who is the listed applicant for CRANIOTOME BLADE OR DRILL BIT?

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

What is the FDA product code for CRANIOTOME BLADE OR DRILL BIT?

The FDA product code for CRANIOTOME BLADE OR DRILL BIT is HBE.

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 A. Henniss 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.

K905445ADSON-BECKMAN RETRACTOR, SPINALK902567STAPLE, SERRATED, FIXATION W/SPIKES, VARIOUS SIZES

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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