FDA.reportPublic FDA data

NON-LOCK SCREW SQUARE DRIVE

Primary DI
00887868075216
Brand
NON-LOCK SCREW SQUARE DRIVE
Company
Biomet Orthopedics, LLC
Model
131827226
Catalog number
131827226
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
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
K132704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132704000DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiomet2013-10-09LXT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868075216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868075216008878680752168878680752160887868075216

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, 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). There are a number of kinds available: 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 across bone fragments.

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
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00887868549236MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549243MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549250MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868549250MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549267MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549274MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549274MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868549281MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549298MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868549298MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549304MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549311MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549311MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868549328MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549328MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868549335MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868549335MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549342MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549342MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868549359MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCLXT2022-11-14
00887868549359MULTI-DIRECTIONAL SCREWBiomet Orthopedics, LLCHRS2022-11-14
00887868544699SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544705SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544712SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544729SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07
00887868544736SMOOTH PEGBiomet Orthopedics, LLCLXT2022-09-07