FDA.reportPublic FDA data

TOGGLELOC WITH ZIPLOOP

Primary DI
00880304478923
Brand
TOGGLELOC WITH ZIPLOOP
Company
Biomet Sports Medicine, LLC
Model
909874
Catalog number
909874
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130033000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130033000TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TOBiomet Manufacturing Corp2013-08-01MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304478923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304478923008803044789238803044789230880304478923

GMDN Terms#

Term, Definition table
TermDefinition
Ligament bone anchorA non-bioabsorbable device designed to be implanted into bone specifically to attach the ends of a ligament (synthetic or natural source) to the bone, e.g., during reconstructive knee surgery. The 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(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
627100159
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304000674MINI HARPOON9029229029222015-10-24
00880304001145HARPOON9029209029202015-10-24
00880304002586TITANIUM INTERFERENCE SCREW9068919068912015-10-24
00880304002821HARPOON9029299029292015-10-24
00880304007048BIO-PHASE II9055029055022015-10-24
00880304008298TI SCREW ES9025549025542015-10-24
00880304008434TI SCREW ES9025569025562015-10-24
00880304009028TITANIUM INTERFERENCE SCREW9096949096942015-10-24
00880304011168TITANIUM INTERFERENCE SCREW9068929068922015-10-24
00880304011175TITANIUM INTERFERENCE SCREW9096489096482015-10-24
00880304116511BONE MULCHCP550800CP5508002015-10-24
00880304117303TITANIUM INTERFERENCE SCREWCP909580CP9095802015-10-24
00880304117310TITANIUM INTERFERENCE SCREWCP909581CP9095812015-10-24
00880304117358TITANIUM INTERFERENCE SCREWCP909585CP9095852015-10-24
00880304404663MINI HARPOON9029239029232015-10-24
00880304405363POLY SUTURE BUTTON9042159042152015-10-24
00880304405387POLY SUTURE BUTTON9042199042192015-10-24
00880304405974NO-PROFILE9045309045302015-10-24
00880304405981NO-PROFILE9045359045352015-10-24
00880304405998NO-PROFILE9045409045402015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867576032Arthrex®ARTHREX, INC.MBI2026-10-20
00888867576056Arthrex®ARTHREX, INC.MBI2026-10-20
00888867627840Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MBI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MBI2026-10-07
00817337000586Integrity Retractable Implant InserterAnika Therapeutics, Inc.MBI2026-10-05
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
20653405546501Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
20653405990724Y-KnotlessTM FlexConmed CorporationMBI2026-02-06
00888867520745Arthrex®ARTHREX, INC.MBI2026-01-21
00840277407962JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407979JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407986JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407993JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408006JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408013JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277408020JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-10-13
00840277407955JuggerKnotless Soft AnchorRIVERPOINT MEDICAL, LLCMBI2025-07-29
07613327662030ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
00840277405012OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405029OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405036OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405043OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405050OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405067OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405074OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMBI2024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SPRIVERPOINT MEDICAL, LLCMBI2024-12-19
00815432026241HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04