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FDA 510(k)

THE GRAFTOLOGER

K-Number: K935753 · 1994-04-25

ApplicantNeoligaments, Ltd.
Decision Date1994-04-25
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

THE GRAFTOLOGER is the device name listed in this FDA 510(k) record. The listed applicant is Neoligaments, Ltd.. It received FDA 510(k) clearance on 1994-04-25 under 510(k) number K935753. 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 THE GRAFTOLOGER?

THE GRAFTOLOGER is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is Neoligaments, Ltd.. The 510(k) number is K935753.

When did THE GRAFTOLOGER receive FDA 510(k) clearance?

THE GRAFTOLOGER received FDA 510(k) clearance on 1994-04-25, under 510(k) number K935753.

Who is the listed applicant for THE GRAFTOLOGER?

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

What is the FDA product code for THE GRAFTOLOGER?

The FDA product code for THE GRAFTOLOGER is HWE.

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Other records listing Neoligaments, Ltd. 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.

K941772CRADLE FIXATION DEVICEK952543GRAFTOLOGER PGH & ACL RECONSTRUCTION INSTRUMENT SETK930339REAMER BITK913461FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEMK911445FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEMK904340FASTLOK (STAPLE AND BUCKLE) FIXATION SYSTEM

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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