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FDA 510(k)

ADD-ON CONDYLE

K-Number: K002790 · 2001-08-06

ApplicantWalter Lorenz Surgical, Inc.
Decision Date2001-08-06
Product CodeNEI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADD-ON CONDYLE is the device name listed in this FDA 510(k) record. The listed applicant is Walter Lorenz Surgical, Inc.. It received FDA 510(k) clearance on 2001-08-06 under 510(k) number K002790. The device is classified under product code NEI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADD-ON CONDYLE?

ADD-ON CONDYLE is a medical device that received FDA 510(k) clearance on 2001-08-06. The listed applicant is Walter Lorenz Surgical, Inc.. The 510(k) number is K002790.

When did ADD-ON CONDYLE receive FDA 510(k) clearance?

ADD-ON CONDYLE received FDA 510(k) clearance on 2001-08-06, under 510(k) number K002790.

Who is the listed applicant for ADD-ON CONDYLE?

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

What is the FDA product code for ADD-ON CONDYLE?

The FDA product code for ADD-ON CONDYLE is NEI.

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Other records listing Walter Lorenz Surgical, 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.

K063386LORENZ ORTHODONTIC ANCHORAGE SYSTEMK063052LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATESK063506LORENZ STERNAL CLOSURE SYSTEMK062842TWIST DRILLK061384LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUMK042516OTOMIMIX

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Related Devices (Code: NEI)

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.

K081747MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMSynthes (Usa)K063181SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEMSynthes (Usa)K031701OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEMOsteomed LPK990667KLS-MARTIN TEMPORARY CONDYLAR IMPLANTKLS-Martin L.P.K990637SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEADSynthes (Usa)

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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