FDA.reportPublic FDA data

JuggerLoc™ Soft Tissue Fixation

Primary DI
00880304682894
Brand
JuggerLoc™ Soft Tissue Fixation
Company
Biomet Orthopedics, LLC
Model
110010374
Catalog number
110010374
Published
2021-09-24
Public version status
Update
Distribution status
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
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
K141263000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141263000TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITSBiomet Manufacturing Corp2014-11-19JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304682894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304682894008803046828948803046828940880304682894

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(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
00880304737488Cartridge Thread Adapter1100301661100301662020-02-13
05019279925377Cobalt MV Bone Cement4024384024382015-11-28
00880304370456CEMENT NOZZLE4149914149912017-07-28
00880304370517OPTIVAC415441542017-07-28
00880304476783Cobalt MV with Gentamicin4024394024392015-11-28
00880304560789Cobalt Bone Cement4022824022822015-11-28
00880304560796Cobalt HV with Gentamicin4022834022832015-11-28
00887868494758Vanguard® Instruments32-48625932-4862592022-05-25
00888480584162PRO OSTEON 2002B0402B0402015-10-24
00888480584179PRO OSTEON 2002B0452B0452015-10-24
00888480584186PRO OSTEON 2002B0752B0752015-10-24
00888480584247PRO OSTEON 2002G022G022015-10-24
00888480584254PRO OSTEON 2002G052G052015-10-24
00888480584339PRO OSTEON 200R2RG0052RG0052015-10-24
00888480584346PRO OSTEON 200R2RG022RG022015-10-24
00888480584353PRO OSTEON 200R2RG052RG052015-10-24
00888480584360PRO OSTEON 200R2RG152RG152015-10-24
00888480584476PRO OSTEON 5005B0405B0402015-10-24
00888480584483PRO OSTEON 5005B0755B0752015-10-24
00888480584490PRO OSTEON 5005B1005B1002015-10-24

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