FDA.reportPublic FDA data

Fortuna MIS eX-TAB Stabilization System

Primary DI
00850001740586
Brand
Fortuna MIS eX-TAB Stabilization System
Company
OSSO SURGICAL LLC
Model
211-003-55055
Device description
5.5mm x 55mm Pre-Lordosed Rod, Bulleted
Published
2020-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System
OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162576000FORTEZZA Spinal Stabilization SystemOsso Surgical2016-11-10NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001740586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001740586008500017405868500017405860850001740586

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081363044
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001740821Fortuna MIS eX-TAB Stabilization System211-003-551402021-06-23
00850001740777Fortuna MIS eX-TAB Stabilization System211-003-551102021-04-23
00850001740784Fortuna MIS eX-TAB Stabilization System211-45035-12021-04-23
00850001740791Fortuna MIS eX-TAB Stabilization System211-45040-12021-04-23
00850001740807Fortuna MIS eX-TAB Stabilization System211-45045-12021-04-23
00850001740814Fortuna MIS eX-TAB Stabilization System211-45050-12021-04-23
00850001740364Fortuna MIS eX-TAB Stabilization System211-55030-12020-09-16
00850001740371Fortuna MIS eX-TAB Stabilization System211-55035-12020-09-16
00850001740388Fortuna MIS eX-TAB Stabilization System211-55040-12020-09-16
00850001740395Fortuna MIS eX-TAB Stabilization System211-55045-12020-09-16
00850001740401Fortuna MIS eX-TAB Stabilization System211-55050-12020-09-16
00850001740418Fortuna MIS eX-TAB Stabilization System211-55055-12020-09-16
00850001740425Fortuna MIS eX-TAB Stabilization System211-65030-12020-09-16
00850001740432Fortuna MIS eX-TAB Stabilization System211-65035-12020-09-16
00850001740449Fortuna MIS eX-TAB Stabilization System211-65040-12020-09-16
00850001740456Fortuna MIS eX-TAB Stabilization System211-65045-12020-09-16
00850001740463Fortuna MIS eX-TAB Stabilization System211-65050-12020-09-16
00850001740470Fortuna MIS eX-TAB Stabilization System211-65055-12020-09-16
00850001740487Fortuna MIS eX-TAB Stabilization System211-75030-12020-09-16
00850001740494Fortuna MIS eX-TAB Stabilization System211-75035-12020-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12