FDA.reportPublic FDA data

Arthrex®

Primary DI
00888867020719
Brand
Arthrex®
Company
ARTHREX, INC.
Model
AR-1670BC
Catalog number
AR-1670BC
Device description
TENO SCRW BIO-COMP
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
MAIFastener, fixation, biodegradable, soft tissue
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888867020719PrimaryGS10
M150AR1670BC1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888867020719008888670207198888670207190888867020719

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA 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 is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867560475Arthrex®AR-9001A-5100AR-9001A-51002026-06-11
00888867561793Arthrex®AR-9850DSAR-9850DS2026-07-17
10888867501000Arthrex®76-1023076-102302026-03-13
10888867501017Arthrex®76-1023476-102342026-03-13
10888867501031Arthrex®76-1023576-102352026-03-13
10888867501048Arthrex®76-1023676-102362026-03-13
10888867544571Arthrex®71-0000471-000042026-03-13
00888867444966Arthrex®AR-9097-02AR-9097-022025-10-24
00888867444973Arthrex®AR-9097-03AR-9097-032025-10-24
00888867444980Arthrex®AR-9097-04AR-9097-042025-10-24
00888867457782Arthrex®AR-9099-02AR-9099-022025-11-28
00888867429871Arthrex®AR-2600FSB-3AR-2600FSB-32023-05-24
00888867429888Arthrex®AR-2600FSB-4AR-2600FSB-42023-05-24
00888867320734Arthrex®AR-8981BCTJ-CPAR-8981BCTJ-CP2021-06-24
10888867335179Arthrex®AR-18700-71AR-18700-712019-12-23
00888867038417Arthrex®AR-602-48AR-602-482018-06-02
00888867218208Arthrex®AR-1788PJ-CPAR-1788PJ-CP2019-11-15
00888867135697Arthrex®AR-9145-24NLAR-9145-24NL2017-02-15
00888867135765Arthrex®AR-9145-30NLAR-9145-30NL2017-02-15
00888867135840Arthrex®AR-9145-36NLAR-9145-36NL2017-02-15

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Primary DI, Brand, Company table
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07290019361213OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361220OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
00889929072745NEXXT MATRIXX® SI SystemNEXXT SPINE, LLCHWC2026-07-17
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