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FDA 510(k)

OSTEON ADAPTOR/CRADLE

K-Number: K930319 · 1994-01-07

ApplicantUnited American Medical Co., Inc.
Decision Date1994-01-07
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEON ADAPTOR/CRADLE is the device name listed in this FDA 510(k) record. The listed applicant is United American Medical Co., Inc.. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K930319. 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 OSTEON ADAPTOR/CRADLE?

OSTEON ADAPTOR/CRADLE is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is United American Medical Co., Inc.. The 510(k) number is K930319.

When did OSTEON ADAPTOR/CRADLE receive FDA 510(k) clearance?

OSTEON ADAPTOR/CRADLE received FDA 510(k) clearance on 1994-01-07, under 510(k) number K930319.

Who is the listed applicant for OSTEON ADAPTOR/CRADLE?

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

What is the FDA product code for OSTEON ADAPTOR/CRADLE?

The FDA product code for OSTEON ADAPTOR/CRADLE is HWE.

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Other records listing United American Medical Co., 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.

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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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