FDA.reportPublic FDA data

TwinLoop FLEX

Primary DI
34546540678325
Brand
TwinLoop FLEX
Company
STRYKER CORPORATION
Model
3910-405-638
Catalog number
3910-405-638
Device description
3.5mm PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER
Published
2015-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34546540678325PackageGS15In Commercial Distribution
04546540678324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3454654067832534546540678325
04546540678324045465406783244546540678324

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327687637N/A65170400166517-040-0162026-03-19
07613327687644N/A65170400106517-040-0102026-03-19
07613327687651N/A65170700216517-070-0212026-03-19
07613327687668N/A65170480216517-048-0212026-03-19
07613327687675N/A65170400126517-040-0122026-03-19
07613327628357RPS88080000008808-000-0002025-10-01
07613327656763BPX79000120007900-012-0002026-03-04
07613327656770BPX79000130007900-013-0002026-03-04
07613327657760BPX79000340007900-034-0002026-03-04
07613327657777BPX79000150007900-015-0002026-03-04
07613327657784BPX79000310007900-031-0002026-03-04
07613327657791BPX79000990007900-099-0002026-03-04
07613327657807N/A79003760107900-376-0102026-03-04
07613327657814BPX79000370007900-037-0002026-03-04
07613327657821N/A79003770107900-377-0102026-03-04
07613327657838N/A79003780107900-378-0102026-03-04
07613327659429BPX79000250007900-025-0002026-03-04
37613327693288Malis6760-180-0106760-180-010-Z012026-02-25
37613327693295Malis6760-180-0056760-180-005-Z012026-02-25
37613327693363Malis6760-180-0156760-180-015-Z012026-02-25

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Primary DI, Brand, Company table
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00840277405616LigaMend™ (Blue)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405623LigaMend™RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405630Strut SutureRIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405715LigaMend™ Soft Button (Black)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277405722LigaMend™ Soft Button (Blue)RIVERPOINT MEDICAL, LLCMBI2026-03-19
00840277411358No-Tie ButtonRIVERPOINT MEDICAL, LLCMBI2026-03-19
10888867550817Arthrex®ARTHREX, INC.MBI2026-03-12
00888867550827Arthrex®ARTHREX, INC.MBI2026-03-12
00860013967000RapidFix™ All-Suture Dual AnchorSuture Tech, Inc.MBI2026-03-09
00888867569638Arthrex®ARTHREX, INC.MBI2026-03-04
00888867569645Arthrex®ARTHREX, INC.MBI2026-03-04
00888867569652Arthrex®ARTHREX, INC.MBI2026-03-04
00888867573130Arthrex®ARTHREX, INC.MBI2026-03-04
00812444029673OrthoButton ALRIVERPOINT MEDICAL, LLCMBI2026-03-03
00889024706323Jgrknt Large 2.9mm Reusable TrocarZimmer, Inc.MBI2026-02-23
00889024706330Jgrknt Large 2.9mm Reusable GuideZimmer, Inc.MBI2026-02-23
00888867470149Arthrex®ARTHREX, INC.MBI2026-02-08
00888867470170Arthrex®ARTHREX, INC.MBI2026-02-08
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30653405990721Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
00810155330989Tigon MedicalTigon Medical LLCMBI2026-02-04
00810155331214Tigon MedicalTigon Medical LLCMBI2026-02-04
00810155331276Tigon MedicalTigon Medical LLCMBI2026-01-23
00888867520745Arthrex®ARTHREX, INC.MBI2026-01-21
08903993499856AUXILOCK PEEK OPTIMA Screw-In Suture AnchorAuxein Medical Private LimitedMBI2026-01-20
28437019739748QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
28437019739755QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
28437019739762QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14