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FDA 510(k)

SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD

K-Number: K990637 · 1999-10-22

ApplicantSynthes (Usa)
Decision Date1999-10-22
Product CodeNEI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1999-10-22 under 510(k) number K990637. 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 SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD?

SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD is a medical device that received FDA 510(k) clearance on 1999-10-22. The listed applicant is Synthes (Usa). The 510(k) number is K990637.

When did SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD receive FDA 510(k) clearance?

SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD received FDA 510(k) clearance on 1999-10-22, under 510(k) number K990637.

Who is the listed applicant for SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD?

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

What is the FDA product code for SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD?

The FDA product code for SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD is NEI.

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Other records listing Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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 LPK002790ADD-ON CONDYLEWalter Lorenz Surgical, Inc.K990667KLS-MARTIN TEMPORARY CONDYLAR IMPLANTKLS-Martin L.P.

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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