FDA.reportPublic FDA data

ANTHEM

Primary DI
00193982339708
Brand
ANTHEM
Company
GLOBUS MEDICAL, INC.
Model
1181.4207
Device description
Non-Locking Screw, 1.5 x 7mm, Ti
Published
2021-11-25
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
HWCScrew, fixation, bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982339708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982339708001939823397081939823397080193982339708

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
00849044040517N/A632.3002016-01-23
00193982662295ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00012026-03-30
00193982662301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00022026-03-30
00193982662318ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00032026-03-30
00193982662325ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00502026-03-30
00193982662332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00702026-03-30
00193982662349ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00902026-03-30
00193982662356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10502026-03-30
00193982662363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10702026-03-30
00193982662370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10902026-03-30
00193982662387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20502026-03-30
00193982662394ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20902026-03-30
00193982677411ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20702026-03-30
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532014Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10