FDA.reportPublic FDA data

Apelo® / Apelo® MIS

Primary DI
M68120060900000
Brand
Apelo® / Apelo® MIS
Company
ATLAS SPINE, INC.
Model
2006-09-0000
Catalog number
2006-09-0000
Device description
Rod Reducer
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072426000ATLAS SPINE PEDICLE SCREW SYSTEMAtlas Spine, LLC2007-10-19NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68120060900000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(561) 741-1108sales@atlasspine.com

Regulatory Flags#

DUNS number
140801007
Device count
1
Serial number
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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Primary DI, Brand, Company table
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00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
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