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FDA 510(k)

SPACE 360 DELIVERY SYSTEM

K-Number: K070351 · 2007-06-29

ApplicantDfine, Inc.
Decision Date2007-06-29
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPACE 360 DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dfine, Inc.. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K070351. 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 SPACE 360 DELIVERY SYSTEM?

SPACE 360 DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Dfine, Inc.. The 510(k) number is K070351.

When did SPACE 360 DELIVERY SYSTEM receive FDA 510(k) clearance?

SPACE 360 DELIVERY SYSTEM received FDA 510(k) clearance on 2007-06-29, under 510(k) number K070351.

Who is the listed applicant for SPACE 360 DELIVERY SYSTEM?

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

What is the FDA product code for SPACE 360 DELIVERY SYSTEM?

The FDA product code for SPACE 360 DELIVERY SYSTEM is NDN.

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Other records listing Dfine, Inc. 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.

K091310ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682K090986STABILI ERX BONE CEMENT, MODEL 1135,STABILIT VERTEBRAL AUGMENTATION SYSTEM (FOR USE W/ STABILIT ERX BONE CEMENT)K072496MODIFICATION TO SPACE CPSXL BONE CEMENTK061531SPACE CPSXL BONE CEMENT

Related Devices (Code: NDN)

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K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K250637VCFix Spinal SystemAmber ImplantsK243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHyprevention

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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