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FDA 510(k)

MITER ENDOSTEAL BLADE IMPLANT

K-Number: K791204 · 1979-09-28

ApplicantDepuy, Inc.
Decision Date1979-09-28
Product CodeNRQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MITER ENDOSTEAL BLADE IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1979-09-28 under 510(k) number K791204. The device is classified under product code NRQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MITER ENDOSTEAL BLADE IMPLANT?

MITER ENDOSTEAL BLADE IMPLANT is a medical device that received FDA 510(k) clearance on 1979-09-28. The listed applicant is Depuy, Inc.. The 510(k) number is K791204.

When did MITER ENDOSTEAL BLADE IMPLANT receive FDA 510(k) clearance?

MITER ENDOSTEAL BLADE IMPLANT received FDA 510(k) clearance on 1979-09-28, under 510(k) number K791204.

Who is the listed applicant for MITER ENDOSTEAL BLADE IMPLANT?

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

What is the FDA product code for MITER ENDOSTEAL BLADE IMPLANT?

The FDA product code for MITER ENDOSTEAL BLADE IMPLANT is NRQ.

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Other records listing Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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Related Devices (Code: NRQ)

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.

K211872PiezoImplant SystemRex Implants, Inc.K981954VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTSHealthline Implants, Inc.K822969GENERATION 5 LINKOW BLADE IMPLANTSLeonard P. Linkow, D.D.L.K791366ORATRONICS ENDOSSEOUS FRAME ASSEMBLYOratronics, 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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