FDA.reportPublic FDA data

JuggerStitch®

Primary DI
00880304690066
Brand
JuggerStitch®
Company
Biomet Orthopedics, LLC
Model
110024772
Catalog number
110024772
Published
2017-04-26
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
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150424000
K191459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150424000JuggerStitch Meniscal Repair DeviceBiomet Manufacturing Corp2015-05-15MBI
K191459000JuggerStitch Meniscal Repair DeviceBiomet, Inc.2019-09-13MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304690066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304690066008803046900668803046900660880304690066

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue/mesh anchor, non-bioabsorbableA non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e.g., mesh, sutures); it is not intended to anchor soft tissues to bone, and is not intended for ophthalmic use. It is typically a threaded screw-like device, and is made of a material that cannot be chemically degraded or absorbed via natural body processes (e.g., metal, polypropylene); it is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized disposable applicator which may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
Manufacturing date on label
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
08903993303863AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One 1.6mm Suture Tape: WhiteAuxein Medical Private LimitedMBI2026-04-30
08903993457009AUXILOCK® 1.8mm Draw Tight Suture-Based Anchor with One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457368AUXILOCK® 2.8mm Titanium Screw-In Suture Anchor With One #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457375AUXILOCK® 3.5mm Titanium Screw-In Suture Anchor With Two #2 BioBraid: White/BlueAuxein Medical Private LimitedMBI2026-04-30
08903993457467AUXILOCK® GFS Mini, Loop: 15mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-30
08903993457450AUXILOCK® GFS Mini, Loop: 12mm, Button L: 12mm, W: 3.9mmAuxein Medical Private LimitedMBI2026-04-18
08903993499887AUXILOCK® 4.5mm PEEK OPTIMA Screw-In Suture Anchor with Two #2 BioBraid:White/BlAuxein Medical Private LimitedMBI2026-04-18
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
09348215029104Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26
09348215029111Bio-composite ScrewSIGNATURE ORTHOPAEDICS PTY LTDMBI2023-05-26