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510(k) Data Aggregation

K Number

K062992

Device Name

SPINAL SPHERES

Manufacturer

INTERBODY INNOVATIONS LLP

Date Cleared

2007-07-27

(298 days)

Product Code

NVR

Regulation Number

N/A

Intended Use

The Spinal Spheres are intended to be inserted between vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The Spinal Spheres are intended to be used with bone graft.

Device Description

The Spinal Spheres consist of CoCtMo spheres which may be implanted from L3 to S1 to 16 morary stabilization in order to promote fusion. These spheres are available in Ø10-Ø16mm diameters.

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K Number

K051371

Device Name

INTERBODY INNOVATIONS CEMENT RESTRICTOR

Manufacturer

INTERBODY INNOVATIONS LLP

Date Cleared

2005-12-06

(194 days)

Product Code

JDK

Regulation Number

878.3300

Intended Use

This device is intended for use in conjunction with Standard PMMA cement. The Interbody Innovations Cement Restrictors are designed to occlude the medullar canal before the introduction of PMMA, in total hip or knee replacement. This device is not intended for use in spine applications. The safety and effectiveness have not been established when implanted into the spine.

Device Description

The Interbody Innovations Cement Restrictors is a hollow curved rectangular frame that is machined from extruded Polyetheretherketone (PEEK). It contains tantalum inserts that serve as location and orientation markers for radiographs. The device is intended to be used in conjunction with standard PMMA

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