FDA.reportPublic FDA data

Integrated Spine System

Primary DI
00822409030927
Brand
Integrated Spine System
Company
Ortho Development Corporation
Model
158-7555-01
Device description
Diameter 7.5 x 55 mm Pedicle Screw
Published
2015-10-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061524000ISS INTEGRATED SPINE SYSTEMOrtho Development Corp.2006-09-26MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00822409030927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00822409030927008224090309278224090309270822409030927

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length55Millimeter
Outer Diameter7.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)553-9991customerservice@odev.com

Regulatory Flags#

DUNS number
876542390
Device count
1
DM exempt
true
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
00822409130153N/A863-12062025-03-17
00822409130160N/A863-12072025-03-17
00822409130177N/A863-12082025-03-17
00822409130184N/A863-12092025-03-17
00822409130191N/A863-12102025-03-17
00822409130207N/A863-12112025-03-17
00822409130214N/A863-22062025-03-17
00822409130221N/A863-22072025-03-17
00822409130238N/A863-22082025-03-17
00822409130245N/A863-22092025-03-17
00822409130252N/A863-22102025-03-17
00822409130269N/A863-22112025-03-17
00822409082124N/A233-01382026-07-16
00822409082131N/A233-01392026-07-16
00822409082148N/A233-01402026-07-16
00822409082155N/A233-01412026-07-16
00822409082162N/A233-01422026-07-16
00822409082179N/A233-01432026-07-16
00822409082186N/A233-01442026-07-16
00822409082193N/A233-01452026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935677XL AdaptorPREMIA SPINE LTDMNI2026-10-20
07290115935677XL AdaptorPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935905XL Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNH2026-10-20
07290115935912Screwdriver CMPREMIA SPINE LTDMNI2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNI2026-10-20
07290115935929Tube for K-wire over a k-wire technique 470mm (Nitinol)PREMIA SPINE LTDMNH2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNI2026-10-20
07290115935936Tube for XL K-Wire 450mmPREMIA SPINE LTDMNH2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNI2026-10-20
07290115935943Tube for K-Wires of 470mmPREMIA SPINE LTDMNH2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNI2026-10-20
07290115935950Tube for K-Wires up to 340mmPREMIA SPINE LTDMNH2026-10-20
00840019978156Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978163Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978170Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978187Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978194Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978200Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978217Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978224Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978231Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978248Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978255Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978262Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978279Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978286Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978293Reform TiPRECISION SPINE, INC.KWP2026-10-19
00840019978309Reform TiPRECISION SPINE, INC.KWP2026-10-19