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FDA 510(k)

SCIENT'X CEMENT RESTRICTOR

K-Number: K052367 · 2005-10-05

ApplicantScient'X
Decision Date2005-10-05
Product CodeJDK
Advisory CommitteeSU
DecisionUnknown

Device Summary

SCIENT'X CEMENT RESTRICTOR is the device name listed in this FDA 510(k) record. The listed applicant is Scient'X. It received FDA 510(k) clearance on 2005-10-05 under 510(k) number K052367. The device is classified under product code JDK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SCIENT'X CEMENT RESTRICTOR?

SCIENT'X CEMENT RESTRICTOR is a medical device that received FDA 510(k) clearance on 2005-10-05. The listed applicant is Scient'X. The 510(k) number is K052367.

When did SCIENT'X CEMENT RESTRICTOR receive FDA 510(k) clearance?

SCIENT'X CEMENT RESTRICTOR received FDA 510(k) clearance on 2005-10-05, under 510(k) number K052367.

Who is the listed applicant for SCIENT'X CEMENT RESTRICTOR?

The FDA 510(k) record lists Scient'X as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIENT'X CEMENT RESTRICTOR?

The FDA product code for SCIENT'X CEMENT RESTRICTOR is JDK.

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Other records listing Scient'X 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.

K071261ISOBAR SEMI-RIGID DUAL DAMPENERK062912SCIENT'X SPINAL SYSTEMK052763STELLA CERVICAL PLATEK050348CO VERTEBRAL BODY REPLACEMENTK051063POLYAXIAL HEMISPHERICAL SPINAL SCREWSK043001MX POLYAXIAL PEDICLE SCREW

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Related Devices (Code: JDK)

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.

K210062Mectaplug PE IIMedacta International S.A.K061465KMI CEMENT RESTRICTOR IMPLANTKinetikos Medical, Inc.K061698MODIFICATION TO LIFE SPINE CEMENT RESTRICTORLife SpineK060247LIFE SPINE CEMENT RESTRICTORLife SpineK060132SPINAL USA CEMENT RESTRICTOR SYSTEMSpinal USAK051371INTERBODY INNOVATIONS CEMENT RESTRICTORInterbody Innovations, Llp

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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