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FDA 510(k)

SNAP BONE REAMER

K-Number: K935322 · 1994-01-28

ApplicantSurgiquip, Inc.
Decision Date1994-01-28
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SNAP BONE REAMER is the device name listed in this FDA 510(k) record. The listed applicant is Surgiquip, Inc.. It received FDA 510(k) clearance on 1994-01-28 under 510(k) number K935322. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SNAP BONE REAMER?

SNAP BONE REAMER is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Surgiquip, Inc.. The 510(k) number is K935322.

When did SNAP BONE REAMER receive FDA 510(k) clearance?

SNAP BONE REAMER received FDA 510(k) clearance on 1994-01-28, under 510(k) number K935322.

Who is the listed applicant for SNAP BONE REAMER?

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

What is the FDA product code for SNAP BONE REAMER?

The FDA product code for SNAP BONE REAMER is HWE.

Related Clinical Trials

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Other records listing Surgiquip, 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.

K935517SNAP STERNUM SAWK935357SNAP RECIPROCATING SAWK935516SNAP DRILLK931769SNAP OSCILLATING SAW

Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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