FDA.reportPublic FDA data

Threshold Pedicle Screw

Primary DI
M7405307550
Brand
Threshold Pedicle Screw
Company
SPINEOLOGY INC.
Model
10-10-09-25
Catalog number
530-7550
Device description
Pedicle Screw
Published
2015-01-09
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
K143403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143403000Threshold Pedicular Fixation SystemSpineology, Inc.2014-12-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7405307550PrimaryHIBCC0

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length50Millimeter

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
M7401001380OptiLIF Endo, Direct Visualization System102-90-01100-13802026-10-01
M7401001376Threshold Pedicular Fixation System102-88-01100-13762026-08-21
M7401001377Threshold Pedicular Fixation System102-88-02100-13772026-08-21
M7401001378Threshold Pedicular Fixation System102-88-03100-13782026-08-21
M7409200004MIS TLIF System92-02-01920-00042026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157123673ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123680ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123697ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123703ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123710ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123727ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123734ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123741ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123758ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123765ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123772ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123789ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123796ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123802ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123819ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123826ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123833ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123840ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123857ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123864ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123871ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123888ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123895ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123901ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123918ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123925ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123932ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123949ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123956ZAVATION SCREWZavation LLCNKB2026-11-02
00197157123963ZAVATION SCREWZavation LLCNKB2026-11-02