FDA.reportPublic FDA data

ANTHEM

Primary DI
00193982122133
Brand
ANTHEM
Company
GLOBUS MEDICAL, INC.
Model
1170.2110
Device description
ANTHEM Anterolateral Distal Tibia Plate, 2.5mm/3.5mm Polyaxial, Right, 10 hole, 175mm, Ti
Published
2021-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202496000ANTHEM Fracture SystemGlobus Medical, Inc.2020-10-29HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982122133PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982122133001939821221331939821221330193982122133

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25
00889095411263ANTHEM7171.55097171.55092026-09-25
00889095411287ANTHEM7171.55117171.55112026-09-25
00889095411300ANTHEM7171.55137171.55132026-09-25
00889095411324ANTHEM7171.55157171.55152026-09-25
00889095611274ANTHEM2171.65852171.65852026-09-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HRS2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25