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FDA 510(k)

IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II

K-Number: K941960 · 1994-08-17

ApplicantImplantech Associates, Inc.
Decision Date1994-08-17
Product CodeFZE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II is the device name listed in this FDA 510(k) record. The listed applicant is Implantech Associates, Inc.. It received FDA 510(k) clearance on 1994-08-17 under 510(k) number K941960. The device is classified under product code FZE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II?

IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II is a medical device that received FDA 510(k) clearance on 1994-08-17. The listed applicant is Implantech Associates, Inc.. The 510(k) number is K941960.

When did IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II receive FDA 510(k) clearance?

IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II received FDA 510(k) clearance on 1994-08-17, under 510(k) number K941960.

Who is the listed applicant for IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II?

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

What is the FDA product code for IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II?

The FDA product code for IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II is FZE.

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Other records listing Implantech Associates, 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.

K200610Customized Contour ImplantK191130Customized Contour ImplantK172389ePTFE-Coated Auricular ImplantK071470IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXXK052504GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-XK052505CALF IMPLANT, MODEL EC17-X

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Related Devices (Code: FZE)

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.

K241253Medicon Epiplating SystemCmf Medicon Surgical, Inc.K161548Osseointegrated FixturesSouthern Implants (Pty), Ltd.K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.K090630NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)Nobel Biocare ABK071018MONARCH NASAL IMPLANTHanson Medical, Inc.K041690MONARCH NASAL IMPLANTHanson Medical, Inc.

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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