FDA.reportPublic FDA data

MONARCH

Primary DI
10705034062839
Brand
MONARCH
Company
Medos International Sàrl
Model
177483095
Catalog number
177483095
Device description
MONARCH SPINE SYSTEM CLOSED HOOK - NARROW 5.5 x 9.5mm
Published
2019-10-08
Public version status
Update
Distribution status
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
K024348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024348000MONARCH SPINE SYSTEMDepuyacromed2003-01-28MNH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034062839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503406283910705034062839

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system hookAn implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28
10705034643397VELYS4516110614516110612025-03-28
10705034643403VELYS4516110224516110222025-03-28
10705034643410VELYS4516110234516110232025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889929072943Inertia® Pedicle Screw SystemNEXXT SPINE, LLCMNI2026-08-26
00889929072943Inertia® Pedicle Screw SystemNEXXT SPINE, LLCMNH2026-08-26
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18