MONUMENT

Primary DI
00889095170733
Brand
MONUMENT
Company
GLOBUS MEDICAL, INC.
Model
6108.0815
Device description
MONUMENT Trial, Large, 15°, 15mm
Published
2016-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132559000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132559000MONUMENT SPACERSGlobus Medical, Inc.2013-12-30OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095170733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095170733008890951707338890951707330889095170733

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth29Millimeter
Device Size Text, specify0
Height15Millimeter
Width39Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00193982003630N/A6190.00266190.00262026-08-14
00193982016340N/A6178.01676178.01672026-08-14
00193982096274ANTHEM2170.10362170.10362026-08-14
00193982096298ANTHEM2170.10382170.10382026-08-14
00193982096311ANTHEM2170.10402170.10402026-08-14
00193982101909ANTHEM2170.20362170.20362026-08-14
00193982101923ANTHEM2170.20382170.20382026-08-14
00193982101947ANTHEM2170.20402170.20402026-08-14
00193982141097HEDRON1208.0109S1208.0109S2026-08-14
00193982141103HEDRON1208.0111S1208.0111S2026-08-14
00193982141110HEDRON1208.0113S1208.0113S2026-08-14
00193982141127HEDRON1208.0115S1208.0115S2026-08-14
00193982141134HEDRON1208.0117S1208.0117S2026-08-14
00193982141141HEDRON1208.0211S1208.0211S2026-08-14
00193982141158HEDRON1208.0213S1208.0213S2026-08-14
00193982141165HEDRON1208.0215S1208.0215S2026-08-14
00193982141172HEDRON1208.0217S1208.0217S2026-08-14
00193982141189HEDRON1208.0313S1208.0313S2026-08-14
00193982141196HEDRON1208.0315S1208.0315S2026-08-14
00193982141202HEDRON1208.0317S1208.0317S2026-08-14

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Primary DI, Brand, Company table
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