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FDA 510(k)

SPACE CPSXL BONE CEMENT

K-Number: K061531 · 2006-08-30

ApplicantDfine, Inc.
Decision Date2006-08-30
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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 2006-08-30 under 510(k) number K061531. 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 CPSXL BONE CEMENT?

SPACE CPSXL BONE CEMENT is a medical device that received FDA 510(k) clearance on 2006-08-30. The listed applicant is Dfine, Inc.. The 510(k) number is K061531.

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

SPACE CPSXL BONE CEMENT received FDA 510(k) clearance on 2006-08-30, under 510(k) number K061531.

Who is the listed applicant for 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 SPACE CPSXL BONE CEMENT?

The FDA product code for 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CEMENTK070351SPACE 360 DELIVERY 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.

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

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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