FDA.reportPublic FDA data

Spineology Navigation Instruments

Primary DI
M7401610033
Brand
Spineology Navigation Instruments
Company
SPINEOLOGY INC.
Model
16-08-01
Catalog number
161-0033
Device description
Navigation Adapter
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182345000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182345000Spineology Navigation InstrumentsSpineology, Inc.2018-09-21OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7401610033PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6512568500info@spineology.com

Regulatory Flags#

DUNS number
033014361
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7404300035CAPTURE Facet Screw Set System70-02-008-1430-00352026-05-29
M7403030028Discectomy Set15-01-45-1303-00282026-05-28
M7403030029Discectomy Set15-01-45-2303-00292026-05-28
M7403030030Discectomy Set15-01-45-3303-00302026-05-28
M7403030031Discectomy Set15-01-45-4303-00312026-05-28
M7403030032Discectomy Set15-01-45-5303-00322026-05-28
M7403030033Discectomy Set15-01-45-6303-00332026-05-28
M7403030034Discectomy Set15-01-45-7303-00342026-05-28
M7403030035Discectomy Set15-01-45-8303-00352026-05-28
M7403030036Discectomy Set15-01-45-9303-00362026-05-28
M7403030059Discectomy Set15-01-45-10303-00592026-05-28
M7403030060Discectomy Set15-01-45-11303-00602026-05-28
M7401001373MIS TLIF System102-86-01100-13732026-05-21
M7401001371OptiLIF Endo, Direct Visualization System102-84-01100-13712026-04-06
M7406410015Fortress Pedicular Fixation64-02-01641-00152024-01-10
M7406410071Fortress Pedicular Fixation55-03-20641-00712024-01-10
M7408610084Duo Expandable Interbody Fusion System86-11-51861-00842023-12-28
M7407408599Fortress Pedicale Screw10-10-57-45740-85992015-09-17
M7407404525Fortress Pedicale Screw10-10-57-1740-45252015-09-17
M7407404530Fortress Pedicale Screw10-10-57-2740-45302015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422367RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422374RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422381RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422121RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422138RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422145RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422152RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422169RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422176RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422183RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422190RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422206RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422213RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422220RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422237RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422244RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
00840493422251RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-01
M711LS7810Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7820Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31
M711LS7830Navigation - Vector M-SINNO Holdings, Inc.OLO2026-05-31