FDA.reportPublic FDA data

100 DEGREE TUBULAR PLATE

Primary DI
00887868446740
Brand
100 DEGREE TUBULAR PLATE
Company
Biomet Orthopedics, LLC
Model
8514-35-502
Catalog number
851435502
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
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
K111663000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111663000TRAUMA INTERNAL FIXATION SYSTEMSDePuy Orthopaedics, Inc.2012-03-12HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868446740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868446740008878684467408878684467400887868446740

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, sterileA sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).

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
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00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHRS2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHWC2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncHRS2026-08-03
00840097513768Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517568Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517575Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517582Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517599Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517643Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517650Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517667Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517728Ossera™ AFXRestor3d, Inc.HSB2025-05-20
00840097517759Ossera™ AFXRestor3d, Inc.HSB2025-05-20
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B56251201WR0070T10WishBone Plate & Screw SystemWishbone Medical, Inc.HTN2022-07-18
B562PKSMC0635NSLTI0WishBone Plate & Screw SystemWishbone Medical, Inc.HRS2021-09-07
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