FDA.reportPublic FDA data

ARTHRORIVET

Primary DI
00880304421240
Brand
ARTHRORIVET
Company
Biomet Sports Medicine, LLC
Model
905800
Catalog number
905800
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
HRXARTHROSCOPE
JDRSTAPLE, FIXATION, BONE
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
JDRStaple, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951658000
K981798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951658000LACTOSORB POP RIVETPoly-Medics,Inc.1995-07-25JDR
K981798000LACTOSORB POP RIVETBiomet, Inc.1998-07-13JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304421240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304421240008803044212408803044212400880304421240

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA 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 can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

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
07290019361435OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
07290019361442OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
07290019361459OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
07290019361466OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-10-21
04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
00888867627840Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627857Arthrex®ARTHREX, INC.MAI2026-10-07
00888867627864Arthrex®ARTHREX, INC.MAI2026-10-07
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLHRX2026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLHRX2026-09-30
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662054ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
04048551411704NAKarl Storz GmbH & Co. KGHRX2025-03-27
00840277405012OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405029OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405036OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405043OC JuggerKnotless® Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405050OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405067OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405074OC JuggerLoop™ Soft AnchorRIVERPOINT MEDICAL, LLCMAI2024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SPRIVERPOINT MEDICAL, LLCMAI2024-12-19
00888867429857Arthrex®ARTHREX, INC.MAI2023-05-24
00888867429864Arthrex®ARTHREX, INC.MAI2023-05-24
00888867429871Arthrex®ARTHREX, INC.MAI2023-05-24
00888867429888Arthrex®ARTHREX, INC.MAI2023-05-24
00888867389533Arthrex®ARTHREX, INC.MAI2023-05-22
00888867354067Arthrex®ARTHREX, INC.MAI2020-12-15