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FDA 510(k)

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

K-Number: K111667 · 2011-12-05

ApplicantSynthes (Usa)
Decision Date2011-12-05
Product CodeJDS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2011-12-05 under 510(k) number K111667. 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 SUPRAPATELLAR INSERTION INSTRUMENTS?

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2011-12-05. The listed applicant is Synthes (Usa). The 510(k) number is K111667.

When did SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS receive FDA 510(k) clearance?

SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS received FDA 510(k) clearance on 2011-12-05, under 510(k) number K111667.

Who is the listed applicant for SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS?

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 SUPRAPATELLAR INSERTION INSTRUMENTS?

The FDA product code for SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS 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)K111540SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM

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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.

K243608TRIGEN Stable Lock Nut & WasherSmith & Nephew, Inc.K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemSmith & Nephew, Inc.K241804TRIGEN INTERTAN 10S Nail SystemSmith & Nephew, Inc.K233150NET BRAND Osteosynthesis Nailing SystemNarang Medical , Ltd.K230761TRIGEN META-NAIL Nail SystemSmith & Nephew, Inc.K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mmSynthes (USA) Products, LLC

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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