FDA.reportPublic FDA data

TOGGLELOC™ WITH ZIPLOOP™

Primary DI
00880304863422
Brand
TOGGLELOC™ WITH ZIPLOOP™
Company
Biomet Orthopedics, LLC
Model
909874
Catalog number
909874
Published
2017-05-04
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
00880304863422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304863422008803048634228803048634220880304863422

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
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720629959573SINEFIXBaat Medical Products B.V.MBI2026-04-01
08721515510151SINEFIXBaat Medical Products B.V.MBI2026-04-01
08101755018820HerculesIn2Bones USA, LLCMBI2026-03-30
08437019739744QuadLock™ Fixation System 9mmABANZA TECNOMED SL.MBI2026-01-14
08437019739751QuadLock™ Fixation System 10mmABANZA TECNOMED SL.MBI2026-01-14
08437019739768QuadLock™ Fixation System 11mmABANZA TECNOMED SL.MBI2026-01-14
07613327661989KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327661996KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662009KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662023KNOTILUS+STRYKER CORPORATIONMBI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMBI2025-06-16
08437019739867WasherCap™ Fixation System 11mmABANZA TECNOMED SL.MBI2025-03-10
08437019739898WasherCap Mini Fixation system 3.5mmABANZA TECNOMED SL.MBI2025-02-25
08437019739904WasherCap Mini Fixation system 4.5mmABANZA TECNOMED SL.MBI2025-02-25
08800298539143GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539150GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539167GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539174GENIE PEEK/Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539228GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
08800298539235GENIE Bio Knotless AnchorOSTEONIC CO.,Ltd.MBI2025-02-06
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2024-09-19
08720629950464SINEFIXBaat Medical Products B.V.MBI2023-04-11
07630037889397APTUSMedartis AGJDR2023-03-03
07630345795144FairFix Adjustable Button SystemMedacta International SAMBI2023-01-20
07613327562910AlphaVentSTRYKER CORPORATIONMBI2022-02-10
07613327563023AlphaVentSTRYKER CORPORATIONMBI2022-02-10
07613327563030AlphaVentSTRYKER CORPORATIONMBI2022-02-10
07613327563085AlphaVentSTRYKER CORPORATIONMBI2022-02-10
07613327563108AlphaVentSTRYKER CORPORATIONMBI2022-02-10
07613327563115AlphaVentSTRYKER CORPORATIONMBI2022-02-10