FDA.reportPublic FDA data

ZipE® Knotless Tissue Repair and Attachment Devices

Primary DI
10858816006009
Brand
ZipE® Knotless Tissue Repair and Attachment Devices
Company
ZIPTEK LLC
Model
RA6-6550-S
Device description
ZipE® Knotless Tissue Repair and Attachment Devices - RA6-6550-S5.0 mm resorbable plug, 6.5 mm resorbable capture, #2 braided suture, and driverQty. 6
Published
2019-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAIFastener, Fixation, Biodegradable, Soft Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAIFastener, Fixation, Biodegradable, Soft TissueOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162429000ZipE Knotless Tissue Repair and Attachment DevicesZiptek, LLC2017-03-13MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858816006009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085881600600910858816006009

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
035237962
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858816006071ZipE Knotless Tissue Repair and attachment devicesc7-50160-ss712024-07-19
00858816006088Ziptek knotless tissue repair and attachment devicesB56-635-S_D882024-07-19
00858816006101Ziptek knotless tissue repair and attachment devicesB56-793-S_D012024-07-19
00858816006064ZipE Knotless Tissue Repair and Attachment DevicesRb41-S-4642024-06-03
10858816006061Zip E® Knotless Tissue Repair and Attachment DevicesRb41-S-4612024-06-03
10858816006016ZipE® Knotless Tissue Repair and Attachment DevicesRA6-6565-S2019-06-04
10858816006023ZipE® Knotless Tissue Repair and Attachment DevicesA6-6550-S2019-06-04
10858816006030ZipE® Knotless Tissue Repair and Attachment DevicesA6-6545-S2019-06-04
00858816006002ZipE® Knotless Tissue Repair and Attachment DevicesRA6-6550-S2018-09-20
00858816006019ZipE® Knotless Tissue Repair and Attachment DevicesRA6-6565-S2018-09-20
00858816006026ZipE® Knotless Tissue Repair and Attachment DevicesA6-6550-S2018-09-20
00858816006033ZipE® Knotless Tissue Repair and Attachment DevicesA6-6545-S2018-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHMAI2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHMAI2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHMAI2025-10-01
07613327662016KNOTILUS+STRYKER CORPORATIONMAI2025-06-16
07613327662030ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
07613327662047ALPHAVENTSTRYKER CORPORATIONMAI2025-06-16
10886705033317GRYPHON XMedos International SàrlMAI2025-04-22
10886705001040LUPINEDEPUY MITEK, LLCMAI2025-03-04
10886705023868HEALIX TRANSTENDMedos International SàrlMAI2025-03-04
07613327547429DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547436DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547443DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547450DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
07613327547467DELTAStryker Leibinger GmbH & Co. KGMAI2024-09-19
20653405988707Argo Knotless GENESYSConmed CorporationMAI2024-07-22
20653405988714Argo Knotless GENESYSConmed CorporationMAI2024-07-22
10845854045794CROSSFT, HI-FIConmed CorporationMAI2024-04-18
20653405988646Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988653ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988660ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988677Argo Knotless GENESYSConmed CorporationMAI2024-04-12
20653405988684ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
20653405988691ARGO KNOTLESS GENESYS, HI-FIConmed CorporationMAI2024-04-12
07649990202075SupraFuser GeneratorSurgical Fusion Technologies GmbHMAI2024-04-12
07649990202235SF Push-in Anchor 3.0Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202259Stopper S-PI-A1.6Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202266Stopper S-PI-A2.3Surgical Fusion Technologies GmbHMAI2024-04-12
07649990202273Stopper S-PI-A3.0Surgical Fusion Technologies GmbHMAI2024-04-12