FDA.reportPublic FDA data

BIOKNOTLESS ORTHOCORD ETHIBOND

Primary DI
10886705002122
Brand
BIOKNOTLESS ORTHOCORD ETHIBOND
Company
Medos International Sàrl
Model
212726
Catalog number
212726
Device description
BIOKNOTLESS Plus Anchor w/ORTHOCORD PLA Absorbable Anchor, Size 2 (5 metric) ORTHOCORD Braided Composite suture anchor loop, Size 2/0 green ETHIBOND braided polyester suture utility loop.
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
K062170000
K150209000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062170000BIOKNOTLESS AND LUPINE PLUS ANCHORSDepuy Mitek, A Johnson & Johnson Company2006-08-22JDR
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
10886705002122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500212210886705002122

GMDN Terms#

Term, Definition table
TermDefinition
Tendon/ligament bone anchor, bioabsorbableA bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
482661753
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
10886705002085BIOKNOTLESS ORTHOCORD ETHIBOND2127222127222015-09-01
10886705007530HEALIX PEEK ORTHOCORD2222052222052015-09-01
10886705007554HEALIX PEEK ORTHOCORD2222072222072015-09-01
10886705007578HEALIX PEEK ORTHOCORD2222092222092015-09-01
10886705007585HEALIX PEEK ORTHOCORD2222102222102015-09-01
10886705007639HEALIX PEEK ORTHOCORD2222152222152015-09-01
10886705007677HEALIX PEEK ORTHOCORD2222192222192015-09-01
10886705007691HEALIX PEEK ORTHOCORD2222212222212015-09-01
10886705007769ORTHOCORD HEALIX BR2222292222292015-09-01
10886705007783ORTHOCORD HEALIX BR2222322222322015-09-01
10886705007790ORTHOCORD HEALIX BR2222332222332015-09-01
10886705007844ORTHOCORD HEALIX BR2222382222382015-09-01
10886705007851ORTHOCORD HEALIX BR2222392222392015-09-01
10886705013616INTRAFIX2546802546802015-09-01
10886705013623INTRAFIX2546812546812015-09-01
10886705013630INTRAFIX2546822546822015-09-01
10886705013647INTRAFIX2546832546832015-09-01
10886705013654INTRAFIX2546842546842015-09-01
10886705013661INTRAFIX2546852546852015-09-01
10886705032204PUREVUE2423292423292021-05-27

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, LLCMAI2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCMBI2015-09-01
10886705013098INTRAFIXDEPUY MITEK, LLCJDR2015-09-01
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, LLCHWC2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCHTY2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCMAI2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCJDR2015-09-01
10886705002399QUICKANCHOR ETHIBONDDEPUY MITEK, LLCMBI2015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUTDEPUY MITEK, LLCMAI2015-09-01