FDA.reportPublic FDA data

BIO-SAV BONE MILL, DISPOSABLE

Primary DI
B992101000
Brand
BIO-SAV BONE MILL, DISPOSABLE
Company
JB Medical Development, LLC
Model
10-100
Catalog number
10100
Device description
DISPOSABLE, MANUALLY OPERATED BONE MILL THAT SAVES TIME, PRODUCES A BETTER AUTO GRAFT PASTE, AND ELIMINATES CLEANING/STERILIZING WORK IN HOSPITAL SETTING.
Published
2021-05-10
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B992101000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual bone millA manually-operated, non-patient-contact device intended to be used to grind bone into a slurry or a powder for use as a bone matrix for bone regeneration or bone grafting. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8776036333hsjeck@md3inc.com

Regulatory Flags#

DUNS number
873149871
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B99214101010ORDOCK CUP, DISPOSABLE14-101-0114101012022-01-18
B992151000PREFERX DELIVERY SYSTEM, DISPOSABLE15-100151002021-09-29
B992141000ORDOCK PLATFORM, RE-USABLE14-100141002021-02-08
B992141010ORDOCK 2 CUPS, DISPOSABLE14-101141012021-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130207435MSIModern Surgical Instruments LLCLXH2026-07-14
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08809695601903AnyPlus®GS Medical Co., Ltd.LXH2026-04-21
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