FDA.reportPublic FDA data

MBD Medical, LLC

Primary DI
00852406006199
Brand
MBD Medical, LLC
Company
Mbd Medical LLC
Model
601-10
Catalog number
601-10
Device description
BONE PLATE, 10-HOLE, LENGTH 123mm
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141045000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141045000MBD PLATE SYSTEMMbd Medical, LLC2014-06-30HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852406006199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852406006199008524060061998524060061990852406006199

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbable, non-sterileA non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length123Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
610.954.7901rwisniewski@mbdmedical.com

Regulatory Flags#

DUNS number
079844748
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852406006007MBD Medical, LLC251-10251-102015-10-24
00852406006014MBD Medical, LLC251-12251-122015-10-24
00852406006021MBD Medical, LLC251-14251-142015-10-24
00852406006038MBD Medical, LLC251-16251-162015-10-24
00852406006045MBD Medical, LLC251-18251-182015-10-24
00852406006052MBD Medical, LLC251-20251-202015-10-24
00852406006069MBD Medical, LLC251-22251-222015-10-24
00852406006076MBD Medical, LLC251-24251-242015-10-24
00852406006083MBD Medical, LLC402-12402-122015-10-24
00852406006090MBD Medical, LLC402-14402-142015-10-24
00852406006106MBD Medical, LLC402-16402-162015-10-24
00852406006113MBD Medical, LLC402-18402-182015-10-24
00852406006120MBD Medical, LLC402-20402-202015-10-24
00852406006137MBD Medical, LLC402-22402-222015-10-24
00852406006144MBD Medical, LLC402-24402-242015-10-24
00852406006151MBD Medical, LLC601-06601-062015-10-24
00852406006168MBD Medical, LLC601-07601-072015-10-24
00852406006175MBD Medical, LLC601-08601-082015-10-24
00852406006182MBD Medical, LLC601-09601-092015-10-24
00852406006205MBD Medical, LLC601-11601-112015-10-24

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