FDA.reportPublic FDA data

OMNIMAX

Primary DI
00841036274702
Brand
OMNIMAX
Company
BIOMET MICROFIXATION, INC
Model
99-5824
Catalog number
99-5824
Published
2019-10-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZLSCREW, FIXATION, INTRAOSSEOUS
HTYPIN, FIXATION, SMOOTH
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZLScrew, Fixation, IntraosseousDental2
HTYPin, Fixation, SmoothOrthopedic2
JEYPlate, BoneDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202969000
K831005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202969000Biomet Microfixation OmniMax MMF SystemBiomet Microfixation2021-08-05JEY
K831005000WIRE & STEINMAN PINSKirschner Medical Corp.1983-05-18HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036274702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036274702008410362747028410362747020841036274702

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

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
00190776403928MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403935MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436025MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436032MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436049MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436056MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436063MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436070MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436087MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436094MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436100MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436117MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436124MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436131MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776436148MillenniumAvalign Technologies, Inc.HTY2026-07-22
00190776403775MillenniumAvalign Technologies, Inc.HTY2026-07-21
00190776403850MillenniumAvalign Technologies, Inc.HTY2026-07-21
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-07-15
04046826346812MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826416676MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826542337MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826543655MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
04046826552473MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-06-25
05055662968545OrthoSolutions 'System26' Bone ScrewsORTHO SOLUTIONS HOLDINGS LIMITEDHTY2026-06-24