FDA.reportPublic FDA data

Mimix QS

Primary DI
00841036020828
Brand
Mimix QS
Company
BIOMET MICROFIXATION, INC
Model
02-1110
Published
2015-09-11
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
GXPMethyl Methacrylate For Cranioplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023718000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023718000QUICKSET MIMIX BONE VOID FILLERWalter Lorenz Surgical, Inc.2002-12-04GXP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036020828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036020828008410360208288410360208280841036020828

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-medicatedA 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. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
046189866
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841036007621N/A01-037001-03702017-04-06
00841036007638N/A01-037101-03712017-04-06
00841036008819N/A01-145501-14552017-04-11
00841036159139N/A01-037601-03762017-04-06
00841036240448WALTERLORENZ™ SURGICAL ASSIST ARMWAL305WAL3052019-06-17
00888233078986VENAPAX XLVPX40002025-03-31
00888233085021PECTUS BLU (TM)78-820078-82002026-01-27
00888233085038PECTUS BLU (TM)78-825078-82502026-01-27
00841036054229N/A915-2055915-20552015-10-11
00841036077969N/A915-2057915-20572015-10-15
00888233005371PECTUS SYSTEM01-390701-39072020-06-17
00888233011334RIBFIX BLU SYSTEM76-000376-00032020-06-18
00888233011587RIBFIX BLU SYSTEM76-119576-11952020-06-18
008882330161311.5MM SYSTEMSP-2335SP-23352020-06-16
008882330161862.0MM SYSTEMSP-2347SP-23472020-06-16
00888233018272TRAUMAONE SYSTEMSP-3228SP-32282020-06-17
00888233022385N/ASP-3139SP-31392020-06-17
00888233018296N/ASP-32302024-09-26
00888233069342STERNALOCK EZ115.101.04115.101.042024-05-29
00888233069359STERNALOCK EZ115.102.06115.102.062024-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118150271IPSKLS-Martin L.P.GXP2025-12-23
00850391007450Permatage 10ccABYRX, INC.GXP2025-05-21
00888118144430IPSKLS-Martin L.P.GXP2024-10-08
00888118144447IPSKLS-Martin L.P.GXP2024-10-08
00888118144454IPSKLS-Martin L.P.GXP2024-10-08
00888118144461IPSKLS-Martin L.P.GXP2024-10-08
00888118144478IPSKLS-Martin L.P.GXP2024-10-08
00888118144485IPSKLS-Martin L.P.GXP2024-10-08
00888118144492IPSKLS-Martin L.P.GXP2024-10-08
00888118144508IPSKLS-Martin L.P.GXP2024-10-08
00888118144515IPSKLS-Martin L.P.GXP2024-10-08
00888118144522IPSKLS-Martin L.P.GXP2024-10-08
00888118144539IPSKLS-Martin L.P.GXP2024-10-08
00888118144546IPSKLS-Martin L.P.GXP2024-10-08
00888118144553IPSKLS-Martin L.P.GXP2024-10-08
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
08885013201314OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
00888118140050IPSKLS-Martin L.P.GXP2023-03-22
00888118140067IPSKLS-Martin L.P.GXP2023-03-22
00888118140074IPSKLS-Martin L.P.GXP2023-03-22
00888118140081IPSKLS-Martin L.P.GXP2023-03-22
00888118140098IPSKLS-Martin L.P.GXP2023-03-22
00888118140104IPSKLS-Martin L.P.GXP2023-03-22
00888118140111IPSKLS-Martin L.P.GXP2023-03-22
00888118140128IPSKLS-Martin L.P.GXP2023-03-22
00888118140135IPSKLS-Martin L.P.GXP2023-03-22
00888118140142IPSKLS-Martin L.P.GXP2023-03-22
00888118140159IPSKLS-Martin L.P.GXP2023-03-22