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FDA 510(k)

SYNTHES AIR PEN DRIVE (APD) SYSTEM

K-Number: K093361 · 2010-04-14

ApplicantSynthes (Usa)
Decision Date2010-04-14
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SYNTHES AIR PEN DRIVE (APD) 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 2010-04-14 under 510(k) number K093361. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES AIR PEN DRIVE (APD) SYSTEM?

SYNTHES AIR PEN DRIVE (APD) SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-14. The listed applicant is Synthes (Usa). The 510(k) number is K093361.

When did SYNTHES AIR PEN DRIVE (APD) SYSTEM receive FDA 510(k) clearance?

SYNTHES AIR PEN DRIVE (APD) SYSTEM received FDA 510(k) clearance on 2010-04-14, under 510(k) number K093361.

Who is the listed applicant for SYNTHES AIR PEN DRIVE (APD) 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 AIR PEN DRIVE (APD) SYSTEM?

The FDA product code for SYNTHES AIR PEN DRIVE (APD) SYSTEM is HBB.

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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: HBB)

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.

K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AGK172907ELAN 4 Air Motor SystemAesculap, Inc.K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesMedtronic Powered Surgical SolutionsK101168LEGEND POWER ADAPTER MODEL: 6475000Medtronic Sofamor DanekK090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical SolutionsK061297ANSPACH IMRI SAFE SURGICAL DRILL SYSTEMThe Anspach Effort, Inc.

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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