FDA.reportPublic FDA data

NON-LOCK SCREW SQUARE DRIVE

Primary DI
00887868450457
Brand
NON-LOCK SCREW SQUARE DRIVE
Company
Biomet Orthopedics, LLC
Model
131827228
Catalog number
131827228
Published
2020-09-04
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
HRSPlate, fixation, bone
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112345000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112345000DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARL2011-10-31LXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868450457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868450457008878684504578878684504570887868450457

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
00810112592245TriLEAPSynthes GmbHHRS2024-02-23
00810112592252TriLEAPSynthes GmbHHRS2024-02-23
00810112592429TriLEAPSynthes GmbHHRS2024-02-23
00810112592450TriLEAPSynthes GmbHHRS2024-02-23
00810112592467TriLEAPSynthes GmbHHRS2024-02-23
00810112592474TriLEAPSynthes GmbHHRS2024-02-23
00810112592634TriLEAPSynthes GmbHHRS2024-02-23
00810112592832TriLEAPSynthes GmbHHRS2024-02-23
00810112592849TriLEAPSynthes GmbHHRS2024-02-23
00810112592986TriLEAPSynthes GmbHHRS2024-02-22
00810112592993TriLEAPSynthes GmbHHRS2024-02-22
00810112593006TriLEAPSynthes GmbHHRS2024-02-22
00810112593013TriLEAPSynthes GmbHHRS2024-02-22
00810112593020TriLEAPSynthes GmbHHRS2024-02-22
00810112593037TriLEAPSynthes GmbHHRS2024-02-22
00810112593044TriLEAPSynthes GmbHHRS2024-02-22
00810112593051TriLEAPSynthes GmbHHRS2024-02-22
00810112593068TriLEAPSynthes GmbHHRS2024-02-22
00810112593075TriLEAPSynthes GmbHHRS2024-02-22
00810112593082TriLEAPSynthes GmbHHRS2024-02-22
00810112593099TriLEAPSynthes GmbHHRS2024-02-22
00810112593105TriLEAPSynthes GmbHHRS2024-02-22
00810112593112TriLEAPSynthes GmbHHRS2024-02-22
00810112593129TriLEAPSynthes GmbHHRS2024-02-22
00810112593136TriLEAPSynthes GmbHHRS2024-02-22
00810112593143TriLEAPSynthes GmbHHRS2024-02-22
00810112593150TriLEAPSynthes GmbHHRS2024-02-22
00810112593167TriLEAPSynthes GmbHHRS2024-02-22
00810112593174TriLEAPSynthes GmbHHRS2024-02-22
00810112593181TriLEAPSynthes GmbHHRS2024-02-22