FDA.reportPublic FDA data

4WEB Medical

Primary DI
00812998024650
Brand
4WEB Medical
Company
4web Medical
Model
EOTS-SM1806
Catalog number
EOTS-SM1806
Published
2018-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1301850004WEB OSTEOTOMY BONE WEDGE4-Web, Inc.2013-06-07HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812998024650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812998024650008129980246508129980246500812998024650

GMDN Terms#

Term, Definition table
TermDefinition
Metallic osteotomy fusion cage, sterileA sterile device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
021323706
Device count
1
Serial number
true
Manufacturing date on label
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
07901125620742Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620759Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620773Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620780Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620797Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620803Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620810Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620827Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620834Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620841Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620858Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620865Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620872Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620889Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620896Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620902Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620919Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620926Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620933Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620940Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620957Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620964Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620971Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620988Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-27
07901125620537Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620544Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620551Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620568Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620575Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26
07901125620711Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHRS2026-08-26