FDA.reportPublic FDA data

MILAGRO

Primary DI
10886705010806
Brand
MILAGRO
Company
DEPUY MITEK, LLC
Model
231825
Catalog number
231825
Device description
MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLGA 9 x 30mm
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPIN, FIXATION, SMOOTH
HWCScrew, fixation, bone
JDRStaple, fixation, bone
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDRStaple, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032717000
K060830000
K150209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032717000BIOCRYL RAPIDE INTERFERENCE SCREWMitek Worldwide2004-03-31HWC
K060830000MILAGRO INTERFERENCE SCREWDepuy Mitek, A Johnson & Johnson Company2006-06-15HWC
K150209000Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop AncDepuy Mitek, A Johnson and Johnson Company2015-10-06MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705010806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670501080610886705010806

GMDN Terms#

Term, Definition table
TermDefinition
Bioabsorbable orthopaedic bone screwA small, threaded, implantable 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). There are several 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.

Contacts#

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

Regulatory Flags#

DUNS number
190572854
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
03700569633943NANEWCLIP TECHNICSHWC2026-10-01
03700569633967NANEWCLIP TECHNICSHWC2026-10-01
03700569633981NANEWCLIP TECHNICSHWC2026-10-01
03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
00885556838211Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
09353903002468FO Micro Screw SystemFIELD ORTHOPAEDICS PTY LTDHTY2020-05-19
09353903008484FO Micro Screw SystemFIELD ORTHOPAEDICS PTY LTDHTY2019-12-13
00812926029580TigerTrilliant Surgical, LLCHWC2019-08-15
10886705001804QUICKANCHOR ETHIBONDDEPUY MITEK, LLCJDR2015-09-01
10886705002535QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHWC2015-09-01
10886705002542QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHWC2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCHTY2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCJDR2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCMBI2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCMAI2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCJDR2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCMAI2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCHTY2015-09-01
10886705013128INTRAFIXDEPUY MITEK, LLCMBI2015-09-01
10886705022397INTRAFIXDEPUY MITEK, LLCJDR2015-09-01
10886705022397INTRAFIXDEPUY MITEK, LLCHTY2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCJDR2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHWC2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHTY2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCMAI2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCMBI2015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUTDEPUY MITEK, LLCMAI2015-09-01