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FDA 510(k)

MODIFICATION TO SPACE CPSXL BONE CEMENT

K-Number: K072496 · 2007-10-05

ApplicantDfine, Inc.
Decision Date2007-10-05
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SPACE CPSXL BONE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dfine, Inc.. It received FDA 510(k) clearance on 2007-10-05 under 510(k) number K072496. 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 MODIFICATION TO SPACE CPSXL BONE CEMENT?

MODIFICATION TO SPACE CPSXL BONE CEMENT is a medical device that received FDA 510(k) clearance on 2007-10-05. The listed applicant is Dfine, Inc.. The 510(k) number is K072496.

When did MODIFICATION TO SPACE CPSXL BONE CEMENT receive FDA 510(k) clearance?

MODIFICATION TO SPACE CPSXL BONE CEMENT received FDA 510(k) clearance on 2007-10-05, under 510(k) number K072496.

Who is the listed applicant for MODIFICATION TO SPACE CPSXL BONE CEMENT?

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 MODIFICATION TO SPACE CPSXL BONE CEMENT?

The FDA product code for MODIFICATION TO SPACE CPSXL BONE CEMENT is NDN.

Related Clinical Trials

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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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)K070351SPACE 360 DELIVERY SYSTEMK061531SPACE CPSXL BONE CEMENT

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.

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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