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FDA 510(k)

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)

K-Number: K972734 · 1997-09-05

ApplicantMednet Locator, Inc.
Decision Date1997-09-05
Product CodeETB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) is the device name listed in this FDA 510(k) record. The listed applicant is Mednet Locator, Inc.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K972734. The device is classified under product code ETB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)?

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Mednet Locator, Inc.. The 510(k) number is K972734.

When did PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) receive FDA 510(k) clearance?

PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) received FDA 510(k) clearance on 1997-09-05, under 510(k) number K972734.

Who is the listed applicant for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)?

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

What is the FDA product code for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)?

The FDA product code for PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP) is ETB.

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 Mednet Locator, 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.

K001404GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESES, GOLD TOTAL WITH FOUNTIAN HEAD, GOLD PISTONK001406HA/GOLD TOTAL AND PARTIAL, REGULAR AND OFFSET, OSSICULAR REPLACEMENT PROSTHESESK974174ULTRABURK972737CAUSSE PISTONK972735TOTAL OSSICULAR REPLACEMENT PROSTHESIS (TORP)K972126MYRINGOTOMY TUBE

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Related Devices (Code: ETB)

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.

K260718mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)MED-EL Elektromedizinische Geräte GmbHK260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);MED-EL Elektromedizinische Geräte GmbHK241261mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis KitMED-EL Elektromedizinische Geräte GmbHK241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes ProsthesisMED-EL Elektromedizinische Geräte GmbHK130512NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESISHeinz Kurz GmbH MedizintechnikK112616NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESISHeinz Kurz GmbH Medizintechnik

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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