FDA.reportPublic FDA data

NA

Primary DI
10886705013005
Brand
NA
Company
DEPUY MITEK, LLC
Model
254508
Catalog number
254508
Device description
ABSOLUTE Absorbable Interference Screw 10 x 30mm
Published
2015-09-01
Public version status
Update
Distribution status
Not 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
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990454000BIO-INTERFERENCE SCREWInnovasive Devices, Inc.1999-07-01HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705013005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670501300510886705013005

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, bioabsorbableA small, 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 is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). This device may be used in maxillofacial surgery. There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705001804QUICKANCHOR ETHIBOND2120322120322015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705002542QUICKANCHOR ETHIBOND2128672128672015-09-01
10886705003747NA2145282145282015-09-01
10886705006892NA2198132198132017-03-17
10886705006908NA2198142198142017-03-17
10886705006922NA2198162198162017-03-17
10886705013098INTRAFIX2546032546032015-09-01
10886705013104NA2546042546042015-09-01
10886705013128INTRAFIX2546092546092015-09-01
10886705013531INTRAFIX2546712546712015-09-01
10886705020607FMS DUO2845802845802015-09-01
10886705020614FMS SOLO2845902845902015-09-01
10886705022397INTRAFIX2546532546532015-09-01
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023486HEALIX ADVANCE2223342223342015-09-01
10886705002399QUICKANCHOR ETHIBOND2128502128502015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUT2128512128512015-09-01
10886705002443MICROFIX QUICKANCHOR ETHIBOND2128552128552015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782783830TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783847TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783915TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783922TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783939TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783946TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783960TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784141TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784158TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784165TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784264CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784318CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784325CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784523CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784530CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784578CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784585CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19