FDA.reportPublic FDA data

MONARCH

Primary DI
10705034057774
Brand
MONARCH
Company
DEPUY SPINE, LLC
Model
177065060
Catalog number
177065060
Device description
MONARCH SPINE SYSTEM SPINE PLATE,HALF,ONE,1/2 SLOT
Published
2015-09-24
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
K010576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010576000MONARCH SPINE SYSTEMDepuyacromed2001-05-23MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034057774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503405777410705034057774

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

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
107105876
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034471716N/A6983411716983411712022-10-07
10705034570105N\A6983447336983447332022-10-07
10705034570211N/A6983447246983447242022-10-07
10705034570228N\A6983447346983447342022-10-07
10705034570433N/A6983447266983447262022-10-07
10705034570501N\A6983447326983447322022-10-07
10705034570624N/A6983447286983447282022-10-07
10705034570693N\A6983447316983447312022-10-07
10705034570723N/A6983447276983447272022-10-07
10705034458267N/A6983393806983393802022-02-02
10705034137049BENGAL1873011131873011132015-09-24
10705034137056BENGAL1873011141873011142015-09-24
10705034137063BENGAL1873011151873011152015-09-24
10705034137070BENGAL1873011161873011162015-09-24
10705034585321TRIALTIS Spine System5560-12-4560FS5560124560FS2026-05-18
10705034585796TRIALTIS Spine System5560-12-4560S5560124560S2026-05-18
10705034604466TRIALTIS Spine System5560-12-7025CS5560127025CS2026-05-18
10705034359007SPOTLIGHT2829509002829509002016-06-30
10705034217727PIPELINE2871050612871050612019-06-06
10705034217789PIPELINE2871050852871050852019-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678520297S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520297S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520299S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520300S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNH2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.MNI2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNH2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.MNI2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24