FDA.reportPublic FDA data

MIMIX

Primary DI
00841036020965
Brand
MIMIX
Company
BIOMET MICROFIXATION, INC
Model
02-2005
Published
2015-09-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXPMethyl Methacrylate For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990290000CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLERBiomet, Inc.1999-11-18GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036020965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036020965008410360209658410360209650841036020965

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene; it does not contain an antimicrobial agent. Disposable devices dedicated to introduction, preparation or delivery may be packaged with the cement. After application, this device cannot be reused.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
904-741-4400FXJAX-ORDERS@BIOMET.COM

Regulatory Flags#

DUNS number
046189866
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036020811Mimix QS02-11052015-09-11
00841036020828Mimix QS02-11102015-09-11
00841036020996MIMIX02-20102015-09-11
00841036021009MIMIX02-20252015-09-11
00841036141943OTOMIMIX7014-32662015-09-11
00888233025140N/A02-290202-29022020-06-26
00888233025157N/A02-290502-29052020-06-26
00888233025164N/A02-310102-31012020-06-26
00888233025171N/A02-310202-31022020-06-26
00888233025188N/A02-310502-31052020-06-26
00888233025195N/A02-311002-31102020-06-26
00888233025201N/A7014-32667014-32662020-06-26
00841036125844ALLOGENIX02-31012015-09-24
00841036125851ALLOGENIX02-31022015-09-24
00841036125868ALLOGENIX02-31052015-09-24
00841036125875ALLOGENIX02-31102015-09-24
00841036181468ALLOGENIX PLUS02-29022015-09-24
00841036181475ALLOGENIX PLUS02-29052015-09-24
00841036019112N/A02-008302-00832017-06-05
00888233028875Pectus Blu (TM)78-880178-88012026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800065231270TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231287TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231812TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231829TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231836TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231843TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231850TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231867TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231874TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231881TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231898TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231904TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231911TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231928TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231935TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231942TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231959TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231966TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231973TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231980TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231997TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232000TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232017TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232024TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232031TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232048TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.GXP2026-06-05
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02