FDA.reportPublic FDA data

Consensus® Bone Screw

Primary DI
00844588010279
Brand
Consensus® Bone Screw
Company
CONSENSUS ORTHOPEDICS, INC.
Model
0013-1-6560
Catalog number
0013-1-6560
Device description
Cancellous Bone Screw
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
Sterile
true
Single use
true

Contact Domains#

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
00844588010279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588010279008445880102798445880102790844588010279

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter60Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100zjohnson@consensusortho.com

Regulatory Flags#

DUNS number
824905723
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844588000379Consensus® Bone Screw0013-1-65150013-1-65152015-09-24
00844588000386Consensus® Bone Screw0013-1-65200013-1-65202015-09-24
00844588000393Consensus® Bone Screw0013-1-65250013-1-65252015-09-24
00844588000409Consensus® Bone Screw0013-1-65300013-1-65302015-09-24
00844588000416Consensus® Bone Screw0013-1-65350013-1-65352015-09-24
00844588000423Consensus® Bone Screw0013-1-65400013-1-65402015-09-24
00844588000430Consensus® Bone Screw0013-1-65450013-1-65452015-09-24
00844588000447Consensus® Bone Screw0013-1-65500013-1-65502015-09-24
00844588010262Consensus® Bone Screw0013-1-65550013-1-65552015-09-24
00844588010286Consensus® Bone Screw0013-1-65650013-1-65652015-09-24
00844588000010Consensus® Hip System0006-0-28010006-0-28012015-09-24
00844588000027Consensus® Hip System0006-0-28020006-0-28022015-09-24
00844588000034Consensus® Hip System0006-0-28030006-0-28032015-09-24
00844588000041Consensus® Hip System0006-0-32010006-0-32012015-09-24
00844588000058Consensus® Hip System0006-0-32020006-0-32022015-09-24
00844588000065Consensus® Hip System0006-0-32030006-0-32032015-09-24
00844588000072Consensus® Hip System0007-1-22010007-1-22012015-09-24
00844588000089Consensus® Hip System0007-1-22020007-1-22022015-09-24
00844588000096Consensus® Hip System0007-1-22030007-1-22032015-09-24
00844588000102Consensus® Hip System0007-1-22040007-1-22042015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01