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FDA 510(k)

SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)

K-Number: K971544 · 1997-05-28

ApplicantSynthes (Usa)
Decision Date1997-05-28
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1997-05-28 under 510(k) number K971544. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)?

SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) is a medical device that received FDA 510(k) clearance on 1997-05-28. The listed applicant is Synthes (Usa). The 510(k) number is K971544.

When did SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) receive FDA 510(k) clearance?

SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) received FDA 510(k) clearance on 1997-05-28, under 510(k) number K971544.

Who is the listed applicant for SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)?

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) COMPACT AIR DRIVE II (CAD II)?

The FDA product code for SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) is HWE.

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Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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