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FDA 510(k)

SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM

K-Number: K130146 · 2013-05-20

ApplicantSynthes (Usa), LLC
Decision Date2013-05-20
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa), LLC. It received FDA 510(k) clearance on 2013-05-20 under 510(k) number K130146. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM?

SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM is a medical device that received FDA 510(k) clearance on 2013-05-20. The listed applicant is Synthes (Usa), LLC. The 510(k) number is K130146.

When did SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM receive FDA 510(k) clearance?

SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM received FDA 510(k) clearance on 2013-05-20, under 510(k) number K130146.

Who is the listed applicant for SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM?

The FDA 510(k) record lists Synthes (Usa), LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM?

The FDA product code for SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM is NDN.

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Other records listing Synthes (Usa), LLC 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.

K180821TruMatch Graft Cage - Long BoneK161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemK112030SYNTHES RADIAL HEAD PROSTHESIS SYSTEMK120275SYNTHES ACIS/VERTEBRAL SPACER CRK1015362.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM

Related Devices (Code: NDN)

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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