FDA.reportPublic FDA data

GRYPHON X

Primary DI
10886705032983
Brand
GRYPHON X
Company
Medos International Sàrl
Model
271043
Catalog number
271043
Device description
GRYPHON X THREADED BR Anchor _x000D_w/ Dual Strand DYNACORD and Needles
Published
2025-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K243790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243790000GRYPHON™ X Anchor; HEALIX TRANSTEND™ AnchorDepuy Mitek2025-02-05MAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705032983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670503298310886705032983

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

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10878528000645ENVOY671-260-95D67126095D2016-06-30
10878528000652ENVOY671-258-95D67125895D2016-06-30
10878528000669ENVOY671-260-05D67126005D2016-06-30
10878528000676ENVOY671-258-05D67125805D2016-06-30
10878528000898REVIVERC044115RC0441152016-06-30
10878528000911REVIVERC044130RC0441302016-06-30
10878528000942REVIVERC056115RC0561152016-06-30
10878528000959REVIVERC056125RC0561252016-06-30
10886704074816ENVOY671-256-05D67125605D2016-06-30
10886704075066ENVOY671-256-95DB67125695DB2016-06-30
10886704075073ENVOY671-256-95D67125695D2016-06-30
10886704075080ENVOY671-256-05DB67125605DB2016-06-30
10886704075097ENVOY671-258-05DB67125805DB2016-06-30
10886704075103ENVOY671-260-05DB67126005DB2016-06-30
10886704075110ENVOY671-258-95DB67125895DB2016-06-30
10886704075127ENVOY671-260-95DB67126095DB2016-06-30
10886704079248YOGAMC24150ZMC24150Z2017-10-31
10886704079255YOGAMC24150ZBMC24150ZB2017-10-31
10886704079262YOGAMC28150ZMC28150Z2017-10-31
10886704079415YOGAMC28150ZBMC28150ZB2017-10-31

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Primary DI, Brand, Company table
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20653405990939GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990946GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
20653405990953GENESYS™ CrossFT™Conmed CorporationMAI2026-07-31
07290019361206OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361213OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
07290019361220OSSIOfiber® Interference ScrewOSSIO LTDMAI2026-07-19
00888867304598Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304604Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304789Arthrex®ARTHREX, INC.MAI2026-07-08
00888867304796Arthrex®ARTHREX, INC.MAI2026-07-08
00816537023012FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023029FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023036FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023043FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023050FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023067FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00816537023234FiberFIXNANOVA BIO MATERIALS INCMAI2026-06-09
00888867483927Arthrex®ARTHREX, INC.MAI2025-11-06
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
10886705001040LUPINEDEPUY MITEK, LLCMAI2025-03-04