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FDA 510(k)

SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS

K-Number: K072095 · 2007-09-27

ApplicantSynthes (Usa)
Decision Date2007-09-27
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2007-09-27 under 510(k) number K072095. 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) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS?

SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS is a medical device that received FDA 510(k) clearance on 2007-09-27. The listed applicant is Synthes (Usa). The 510(k) number is K072095.

When did SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS receive FDA 510(k) clearance?

SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS received FDA 510(k) clearance on 2007-09-27, under 510(k) number K072095.

Who is the listed applicant for SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS?

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) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS?

The FDA product code for SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS 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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