FDA.reportPublic FDA data

PANALOK ETHIBOND

Primary DI
10886705000807
Brand
PANALOK ETHIBOND
Company
DEPUY MITEK, LLC
Model
210025
Catalog number
210025
Device description
PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.
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
HRXARTHROSCOPE
HTYPIN, FIXATION, SMOOTH
JDRStaple, fixation, bone
MAIFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
MBIFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
JDRStaple, Fixation, BoneOrthopedic2
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150209000
K952687000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
K952687000PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEMETHICON, Inc.1996-02-06MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705000807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500080710886705000807

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature026 Degrees Celsius
Handling Environment Temperature080 Degrees Fahrenheit
Storage Environment Temperature026 Degrees Celsius
Storage Environment Temperature080 Degrees Fahrenheit

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
00860015986504Joint Preservation Innovations, LLCJoint Preservation Innovations, LLCHRX2026-11-05
00860015986511Joint Preservation Innovations, LLCJoint Preservation Innovations, LLCHRX2026-11-05
00889795154804Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
00889795154811Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
00889795154828Grappler® Suture Anchor SystemParagon 28, Inc.MBI2026-11-04
09353903030331OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030348OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
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09353903030386OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030393OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030416OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030430OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
09353903030461OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
09353903030478OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
09353903030485OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
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042503371191664K UHD Foraminoscope (4.7 WCh), ocularJoimax GmbHHRX2026-11-02
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00190776436711MilleniumAvalign Technologies, Inc.HTY2026-10-20