FDA.reportPublic FDA data

Monaco Pedicle Screw System

Primary DI
00843210126739
Brand
Monaco Pedicle Screw System
Company
Altus Spine, LLC
Model
922-6160
Device description
Pre-Lordosed Rod, Monaco
Published
2018-10-02
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
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181339000Altus Spine Pedicle Screw SystemAltus Partners, LLC2018-07-24NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843210126739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210126739008432101267398432101267390843210126739

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
Length160Millimeter
Outer Diameter6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)355-4156Info@altus-spine.com

Regulatory Flags#

DUNS number
078331322
Device count
1
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
00843210143644Monaco Pedicle Screw System880-10442026-08-24
00843210180731Brickyard Stand-Alone ALIF1030-04132024-08-29
00843210176611Indy Standalone1030-04132024-07-24
00843210133478Imola-Silverstone600-31092018-10-06
00843210134161Imola-Silverstone790-00022018-10-06
00843210176567Sochi300-09012025-03-13
00843210167381SochiA16-30-25352024-10-03
00843210167398SochiA16-30-31412024-10-03
00843210167404SochiA16-30-38482024-10-03
B41710010011Monza Cervical Plate System100-10012016-10-28
B41711040121Monza Cervical Plate System110-40122016-10-28
B41711040141Monza Cervical Plate System110-40142016-10-28
B41711040161Monza Cervical Plate System110-40162016-10-28
B41711040181Monza Cervical Plate System110-40182016-10-28
B41711043121Monza Cervical Plate System110-43122016-10-28
B41711043141Monza Cervical Plate System110-43142016-10-28
B41711043161Monza Cervical Plate System110-43162016-10-28
B41711043181Monza Cervical Plate System110-43182016-10-28
B41711140121Fuji Cervical Plate System111-40122017-08-22
B41711140131Fuji Cervical Plate System111-40132017-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
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