FDA.reportPublic FDA data

MBD Medical, LLC

Primary DI
00852406006113
Brand
MBD Medical, LLC
Company
Mbd Medical LLC
Model
402-18
Catalog number
402-18
Device description
4mm BONE SCREW, LENGTH 18mm
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
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, 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
00852406006113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852406006113008524060061138524060061130852406006113

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Millimeter
Outer Diameter4Millimeter

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
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
00852406006199MBD Medical, LLC601-10601-102015-10-24
00852406006205MBD Medical, LLC601-11601-112015-10-24

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