FDA.reportPublic FDA data

HEALIX ADVANCE DYNATAPE DYNACORD

Primary DI
10886705031115
Brand
HEALIX ADVANCE DYNATAPE DYNACORD
Company
Medos International Sàrl
Model
280719
Catalog number
280719
Device description
HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm White/Black DYNATAPE Braided Flat Suture, 36inch (91 cm) and (1) Blue, Size 2 (5 metric) DYNACORD Braided Suture, 36inch (91cm), (1) Utility Shuttle Suture WHITE 6.5mm
Published
2020-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone
MBIFastener, fixation, nondegradable, soft tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2
MBIFastener, Fixation, Nondegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200949000HEALIX ADVANCE Anchor with DYNATAPE SutureMedos International SARL2020-06-04MBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705031115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670503111510886705031115

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034442280EXPEDIUM VERSE™ SPINE SYSTEM1997216401997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEM1997214601997214602015-09-24
10705034369761SKYLINE4102701124102701122016-12-31
10705034369778SKYLINE4102701164102701162016-12-31
10705034369785SKYLINE4102701204102701202016-12-31
10705034369822SKYLINE4102702284102702282016-12-31
10705034369839SKYLINE4102702324102702322016-12-31
10705034369846SKYLINE4102702364102702362016-12-31
10705034369884SKYLINE4102703424102703422016-12-31
10705034369891SKYLINE4102703484102703482016-12-31
10705034369907SKYLINE4102703544102703542016-12-31
10705034369983SKYLINE4102901304102901302016-12-31
10705034648194VELYS4516110654516110652026-10-09
10705034648200VELYS4516110644516110642026-10-09
00856879006519FIBERGRAFT Aeridyan59000170590001702026-09-29
00856879006908FIBERGRAFT Aeridyan Matrix73000030730000302023-04-05
00856879006915FIBERGRAFT Aeridyan Matrix73000063730000632023-04-05
00856879006922FIBERGRAFT Aeridyan Matrix73000125730001252023-04-05
00856879006946FIBERGRAFT Aeridyan Matrix73000200730002002023-04-05
00856879006250FIBERGRAFT Aeridyan Matrix59000125590001252021-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
09353903030379OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDMBI2026-11-04
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
00841731132642REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132659REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132666REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132673REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132680REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132697REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132703REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132710REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132727REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132734REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132741REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132758REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132765REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132772REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132789REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132796REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132802REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132819REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132826REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132833REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03