FDA.reportPublic FDA data

4WEB Medical

Primary DI
00810074753517
Brand
4WEB Medical
Company
4web Medical
Model
ATS-000007
Catalog number
ATS-000007
Published
2025-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SAIAnkle Fusion Cage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAIAnkle Fusion CageOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810074753517PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810074753517008100747535178100747535170810074753517

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021323706
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008129980540084WEB MedicalATS-020000-05ATS-020000-052024-11-22
008129980540154WEB MedicalATS-020000-06ATS-020000-062024-11-22
008129980540224WEB MedicalATS-020000-07ATS-020000-072024-11-22
008129980540394WEB MedicalATS-020000-08ATS-020000-082024-11-22
008129980540464WEB MedicalATS-020000-09ATS-020000-092024-11-22
008129980540534WEB MedicalATS-020000-10ATS-020000-102024-11-22
008129980544284WEB MedicalATS-020000-01ATS-020000-012024-11-22
008100747560134WEB Medical4WEB-0000074WEB-0000072023-02-09
008129980522574WEB MedicalCSTS2-MD1206-SPCSTS2-MD1206-SP2026-04-28
008129980568284WEB MedicalLSTS-SM0608-MS2LSTS-SM0608-MS22026-04-07
008129980568354WEB MedicalLSTS-SM0610-MS2LSTS-SM0610-MS22026-04-07
008129980568424WEB MedicalLSTS-SM0612-MS2LSTS-SM0612-MS22026-04-07
008129980568594WEB MedicalLSTS-SM1208-MS2LSTS-SM1208-MS22026-04-07
008129980568664WEB MedicalLSTS-SM1210-MS2LSTS-SM1210-MS22026-04-07
008129980568734WEB MedicalLSTS-SM1212-MS2LSTS-SM1212-MS22026-04-07
008129980568804WEB MedicalLSTS-MD0608-MS2LSTS-MD0608-MS22026-04-07
008129980568974WEB MedicalLSTS-MD0610-MS2LSTS-MD0610-MS22026-04-07
008129980569034WEB MedicalLSTS-MD0612-MS2LSTS-MD0612-MS22026-04-07
008129980569104WEB MedicalLSTS-MD1208-MS2LSTS-MD1208-MS22026-04-07
008129980569274WEB MedicalLSTS-MD1210-MS2LSTS-MD1210-MS22026-04-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097534169Ossera™ AFX InstrumentationRestor3d, Inc.SAI2026-05-14
00840097534176Ossera™ AFX InstrumentationRestor3d, Inc.SAI2026-05-14
00840097513256Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097513263Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097513270Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097513287Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097515724Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097515731Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097519333Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519340Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519357Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519364Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519371Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097519388Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097532370Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097532387Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533599Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533612Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533629Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533636Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533643Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533650Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533667Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533674Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097533711Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097533728Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097533735Ossera™ AFXRestor3d, Inc.SAI2025-12-18
00840097534367Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097534374Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18
00840097534381Ossera™ AFX InstrumentationRestor3d, Inc.SAI2025-12-18