FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998038572
Brand
4WEB Medical
Company
4web Medical
Model
CSTS-SA-000001
Catalog number
CSTS-SA-000001
Published
2019-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
OVEIntervertebral Fusion Device With Integrated Fixation, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812998038572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998038572008129980385728129980385720812998038572

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). 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
008129980366464WEB MedicalASTS-MD1216-LPASTS-MD1216-LP2020-07-17
008129980366534WEB MedicalASTS-MD1216-LPASTS-MD1216-LP2020-07-17
008129980264564WEB MedicalASTS-LG1210-LPASTS-LG1210-LP2018-12-14
008129980264634WEB MedicalASTS-LG1212-LPASTS-LG1212-LP2018-12-14
008129980264874WEB MedicalASTS-LG0610-LPASTS-LG0610-LP2018-12-14
008129980264944WEB MedicalASTS-LG0612-LPASTS-LG0612-LP2018-12-14
008129980265004WEB MedicalASTS-LG0614-LPASTS-LG0614-LP2018-12-14
008129980265174WEB MedicalASTS-MD1210-LPASTS-MD1210-LP2018-12-14
008129980265244WEB MedicalASTS-MD1212-LPASTS-MD1212-LP2018-12-14
008129980265314WEB MedicalASTS-MD1214-LPASTS-MD1214-LP2018-12-14
008129980346974WEB MedicalASTS-MD1210-LP-SASTS-MD1210-LP-S2018-12-14
008129980347034WEB MedicalASTS-MD1212-LP-SASTS-MD1212-LP-S2018-12-14
008129980347104WEB MedicalASTS-MD1214-LP-SASTS-MD1214-LP-S2018-12-14
008129980347274WEB MedicalASTS-LG0610-LP-SASTS-LG0610-LP-S2018-12-14
008129980347344WEB MedicalASTS-LG0612-LP-SASTS-LG0612-LP-S2018-12-14
008129980347414WEB MedicalASTS-LG0614-LP-SASTS-LG0614-LP-S2018-12-14
008129980347584WEB MedicalASTS-LG1210-LP-SASTS-LG1210-LP-S2018-12-14
008129980347654WEB MedicalASTS-LG1212-LP-SASTS-LG1212-LP-S2018-12-14
008129980358544WEB MedicalASTS-MD1216-LP-SASTS-MD1216-LP-S2018-12-14
008129980540084WEB MedicalATS-020000-05ATS-020000-052024-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.OVE2026-10-01
00888867620612Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00810204090017Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090024Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090031Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090048Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090055Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090062Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090079Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090086Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090093Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090109Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090116Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090123Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090130Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090147Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090154Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090161Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090178Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090185Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00810204090192Tailored-H Cervical Standalone SystemDemetra, Inc.OVE2026-09-30
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29