FDA.reportPublic FDA data

EZLOC

Primary DI
00880304457348
Brand
EZLOC
Company
Biomet Sports Medicine, LLC
Model
904785
Catalog number
904785
Published
2015-10-24
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
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041261000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041261000FEMORAL HOOKArthrotek, Inc.2004-06-07MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304457348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304457348008803044573488803044573480880304457348

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
00810155331412Tigon MedicalTigon Medical LLCMBI2026-07-09
00850029805106Tigon MedicalTigon Medical LLCMBI2026-06-26
07901125601130GMReis Suture AnchorsGM DOS REIS INDUSTRIA E COMERCIO LTDAMBI2026-06-25
09353903030201Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-06-24
00860013918606ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918613ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918620ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
00860013918637ArthroTAK Tendon Anchor KitARTHROTAK, LLCMBI2026-06-08
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
09353903030003Griplasty SystemFIELD ORTHOPAEDICS PTY LTDMBI2024-09-19
10818674027097FiberStitch™ Implant 1.5, Curved with two Polyester Implants and 2-0 FiberWire®T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2023-09-27
10818674027103FiberStitch™ Implant 1.5, Straight with two Polyester Implants and 2-0 FiberWireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2023-09-27
10818674027110FiberStitch™ Implant 1.5, Reverse Curved with two Polyester Implants and 2-0 FibT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2023-09-27
10818674027127FiberStitch™ Implant 1.5, 24° Curved with two Polyester Implants and 2-0 FiberWiT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONMBI2023-09-27
08720629950464SINEFIXBaat Medical Products B.V.MBI2023-04-11
07630345795144FairFix Adjustable Button SystemMedacta International SAMBI2023-01-20
07613327562910AlphaVentSTRYKER CORPORATIONMBI2022-02-10