FDA.reportPublic FDA data

HiJAK™ Cervical

Primary DI
M68120190100090
Brand
HiJAK™ Cervical
Company
ATLAS SPINE, INC.
Model
2019-01-0009
Catalog number
2019-01-0009
Device description
Cervical Distractor, HiJAK™ Cervical
Published
2019-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

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
K180675000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180675000Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.2018-06-13ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68120190100090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200030743CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030767CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030781CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030804CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030828CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030842CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030866CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030880CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030903CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030927CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200030965CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031023CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031047CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031061CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031085CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031108CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031122CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031146CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031160CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031184CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031207CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031221CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031245CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031269CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031283CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031306CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031320CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031344CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031368CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17
18257200031382CONSTRUX - MINI PTCOrthofix US LLCODP2026-07-17