FDA.reportPublic FDA data

MULTIDIRECTIONAL SCREW

Primary DI
00887868547591
Brand
MULTIDIRECTIONAL SCREW
Company
Biomet Orthopedics, LLC
Model
8163-35-075
Catalog number
816335075
Published
2022-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTNWASHER, BOLT NUT
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone
JDWPIN, FIXATION, THREADED
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTNWasher, Bolt NutOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDWPin, Fixation, ThreadedOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal CompositeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090877000PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWSDePuy Orthopaedics, Inc.2009-06-26HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868547591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868547591008878685475918878685475910887868547591

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556836187Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836163Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836170Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836194Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836200Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836217Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836224Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836248Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836255Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836262Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835999Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836002Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836019Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836026Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836033Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836040Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836057Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836064Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836071Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836088Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836095Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836118Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836125Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836132Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836149Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836156Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556838785Total Foot System 2Smith & Nephew, Inc.HRS2022-12-21
00885556838785Total Foot System 2Smith & Nephew, Inc.HWC2022-12-21
00888867007475Arthrex®ARTHREX, INC.HRS2017-02-15
00888867007499Arthrex®ARTHREX, INC.HRS2017-02-15