FDA.reportPublic FDA data

N/A

Primary DI
00841036019532
Brand
N/A
Company
BIOMET MICROFIXATION, INC
Model
02-0231
Catalog number
02-0231
Published
2017-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWMOSTEOTOME

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841036019532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841036019532008410360195328410360195320841036019532

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
00810220800270Adler Instrument CompanyAdler, Inc.HWM2026-05-26
00810220800287Adler Instrument CompanyAdler, Inc.HWM2026-05-26
10885862663238N/AExactech, Inc.HWM2026-03-19
00190776417796MillenniumAvalign Technologies, Inc.HWM2026-03-11
00190776417802MillenniumAvalign Technologies, Inc.HWM2026-03-11
M9307867516310Life InstrumentsLife Instrument CorporationHWM2026-03-06
00840319758861Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00840319758878Hayden MedicalHayden Medical, Inc.HWM2026-03-05
00190776417611MillenniumAvalign Technologies, Inc.HWM2026-03-04
04046826118327MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
04046826118341MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWM2026-02-27
03662663109598Mergence-A Preparation InstrumentationHighridge Medical, LLCHWM2026-02-11
03662663131780Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWM2026-02-11
10886982361295NASynthes GmbHHWM2026-02-11
00840277133243Innomed, Inc.INNOMED, INC.HWM2026-02-06
00840277133250Innomed, Inc.INNOMED, INC.HWM2026-02-06
03662663084079ActivLHighridge Medical, LLCHWM2026-02-03
00190776415464MillenniumAvalign Technologies, Inc.HWM2026-01-27
03662663155786Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663155809Zyston Interbody Spacer SystemHighridge Medical, LLCHWM2025-12-29
03662663216005Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216012Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216241Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216258Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216265Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216319Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216326Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216333Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216340Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17
03662663216357Vital Spinal Fixation SystemHighridge Medical, LLCHWM2025-12-17