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FDA 510(k)

SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM

K-Number: K972516 · 1997-09-04

ApplicantSynthes (Usa)
Decision Date1997-09-04
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1997-09-04 under 510(k) number K972516. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM?

SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-04. The listed applicant is Synthes (Usa). The 510(k) number is K972516.

When did SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM receive FDA 510(k) clearance?

SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM received FDA 510(k) clearance on 1997-09-04, under 510(k) number K972516.

Who is the listed applicant for SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM?

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 (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM?

The FDA product code for SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM is JDS.

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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: JDS)

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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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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