FDA.reportPublic FDA data

Fortress Set Screw

Primary DI
M7406406000
Brand
Fortress Set Screw
Company
SPINEOLOGY INC.
Model
10-10-53-2
Catalog number
640-6000
Device description
Set Screw
Published
2014-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140010000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140010000FORTRESS PEDICLE SCREW SYSTEMSpineology, Inc.2014-04-23NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7406406000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw (screw head), anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(651)256-8500info@spineology.com

Regulatory Flags#

DUNS number
033014361
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7403030001Discectomy Set10-01-138303-00012026-07-08
M7403030002Discectomy Set10-01-139303-00022026-07-08
M7403030069Discectomy Set15-01-58303-00692026-07-08
M7403030070Discectomy Set15-01-59303-00702026-07-08
M7403030071Discectomy Set15-01-60303-00712026-07-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-13