FDA.reportPublic FDA data

Rebar®

Primary DI
M681SCC0010140
Brand
Rebar®
Company
ATLAS SPINE, INC.
Model
SCC-001-014
Catalog number
SCC-001-014
Device description
14mm Lordotic Spacer
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081880000ATLAS SPINE SPACERAtlas Spine, Inc.2008-10-02ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M681SCC0010140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
140801007
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M68111230100070HiJAK™ Stand Alone1123-01-00071123-01-00072020-09-23
M68111230100080HiJAK™ Stand Alone1123-01-00081123-01-00082020-09-23
M68111230100090HiJAK™ Stand Alone1123-01-00091123-01-00092020-09-23
M68111230100100HiJAK™ Stand Alone1123-01-00101123-01-00102020-09-23
M68111230100110HiJAK™ Stand Alone1123-01-00111123-01-00112020-09-23
M68111230100120HiJAK™ Stand Alone1123-01-00121123-01-00122020-09-23
M68111230100130HiJAK™ Stand Alone1123-01-00131123-01-00132020-09-23
M68111230100140HiJAK™ Stand Alone1123-01-00141123-01-00142020-09-23
M68111230200070HiJAK™ Stand Alone1123-02-00071123-02-00072020-09-23
M68111230200080HiJAK™ Stand Alone1123-02-00081123-02-00082020-09-23
M68111230200090HiJAK™ Stand Alone1123-02-00091123-02-00092020-09-23
M68111230200100HiJAK™ Stand Alone1123-02-00101123-02-00102020-09-23
M68111230200110HiJAK™ Stand Alone1123-02-00111123-02-00112020-09-23
M68111230200120HiJAK™ Stand Alone1123-02-00121123-02-00122020-09-23
M68111230200130HiJAK™ Stand Alone1123-02-00131123-02-00132020-09-23
M68111230200140HiJAK™ Stand Alone1123-02-00141123-02-00142020-09-23
M68111230300080HiJAK™ Stand Alone1123-03-00081123-03-00082020-09-23
M68111230300090HiJAK™ Stand Alone1123-03-00091123-03-00092020-09-23
M68111230300100HiJAK™ Stand Alone1123-03-00101123-03-00102020-09-23
M68111230300110HiJAK™ Stand Alone1123-03-00111123-03-00112020-09-23

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