FDA.reportPublic FDA data

TraumaOne SYSTEM

Primary DI
00888233008884
Brand
TraumaOne SYSTEM
Company
BIOMET MICROFIXATION, INC
Model
43-1016
Catalog number
43-1016
Published
2020-06-17
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
HWCScrew, fixation, bone
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081067000
K113512000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081067000FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)Biomet Microfixation, Inc.2008-05-09JEY
K113512000BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEMBiomet Microfixation2012-06-29JEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888233008884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888233008884008882330088848882330088840888233008884

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial fixation plate, non-bioabsorbableA small implantable plate/set of plates designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize a fracture gap or craniotomy flap, and/or cover a burr hole; the material cannot be chemically degraded or absorbed by natural body processes. It is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover) and includes implant-grade metal; in addition to the plate(s) bone screws may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)741-4400FXJAX-ORDERS@ZIMMERBIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00810128536875PECTUS BLU (TM)78-850078-85002024-09-30
00888233077170PECTUS BLU (TM)78-800078-80002024-09-30
00888233077187PECTUS BLU (TM)78-808078-80802024-09-30
00888233077194PECTUS BLU (TM)78-808178-80812024-09-30
00888233077200PECTUS BLU (TM)78-808278-80822024-09-30
00888233077224PECTUS BLU (TM)78-830078-83002024-09-30
00888233077231PECTUS BLU (TM)78-835078-83502024-09-30
00888233077248PECTUS BLU (TM)78-840078-84002024-09-30
00888233077255PECTUS BLU (TM)78-845078-84502024-09-30
00888233077279PECTUS BLU (TM)78-855078-85502024-09-30
00888233028776PECTUS BLU (TM)78-001078-00102022-02-09
00888233028783PECTUS BLU (TM)78-001178-00112022-02-09
00888233028790PECTUS BLU (TM)78-001278-00122022-02-09
00888233028806PECTUS BLU (TM)78-002078-00202022-02-09
00888233028813PECTUS BLU (TM)78-003078-00302022-02-09
00888233028837PECTUS BLU (TM)78-004078-00402022-02-09
00888233028844PECTUS BLU (TM)78-005078-00502022-02-09
00888233028851PECTUS BLU (TM)78-005178-00512022-02-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140425ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140432ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140524ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140548ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140692ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140708ARTEMIS FUZEVILEX LLCHWC2026-07-22