FDA.reportPublic FDA data

restor3d Osteotomy Wedge

Primary DI
00840097502816
Brand
restor3d Osteotomy Wedge
Company
Restor3d, Inc.
Model
1101-009-18160818
Device description
Titanium (Ti-6Al-4V) Evans Wedge 009, Small Footprint, 8mm Thickness
Published
2021-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PLFBone Wedge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLFBone WedgeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191047000ADI TiDAL Osteotomy WedgeAdditive Device, Inc. (Adi) D/B/A Restor3D2019-11-05PLF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840097502816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097502816008400975028168400975028160840097502816

Regulatory Flags#

DUNS number
080819836
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840097503011restor3d Osteotomy Wedge1100-002-221409072021-09-01
00840097503028restor3d Osteotomy Wedge1100-002-221410072021-09-01
00840097503073restor3d Osteotomy Wedge1100-002-221405072021-09-01
00840097503080restor3d Osteotomy Wedge1100-002-221406072021-09-01
00840097503097restor3d Osteotomy Wedge1100-002-221407072021-09-01
00840097503103restor3d Osteotomy Wedge1100-002-221408072021-09-01
00840097504674restor3d Osteotomy Wedge1100-002-221405102022-08-18
00840097504681restor3d Osteotomy Wedge1100-002-221406132022-08-18
00840097504698restor3d Osteotomy Wedge1100-002-221407152022-08-18
00840097504704restor3d Osteotomy Wedge1100-002-221408182022-08-18
00840097504711restor3d Osteotomy Wedge1100-002-221410232022-08-18
00840097504728restor3d Osteotomy Wedge1100-002-221412282022-08-18
00840097504735restor3d Osteotomy Wedge1100-002-181205132022-08-18
00840097504742restor3d Osteotomy Wedge1100-002-181206162022-08-18
00840097504759restor3d Osteotomy Wedge1100-002-181207192022-08-18
00840097504766restor3d Osteotomy Wedge1100-002-181208222022-08-18
00840097504773restor3d Osteotomy Wedge1100-002-181210282022-08-18
00840097504780restor3d Osteotomy Wedge1100-002-181212342022-08-18
00840097503110restor3d Disposable Instrument, Wedge Trial6100-NSP-A04052021-11-15
00840097503127restor3d Disposable Instrument, Wedge Trial6100-NSP-A05062021-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G817103151100SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817103151200SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G81711325141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S101181806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-06
G817S111121605SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121606SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121607SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121608SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121610SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111121612SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141805SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141806SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141807SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141808SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141810SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
G817S111141812SiNAPTIC Osteotomy Wedge SystemSINTX Technologies, Inc.PLF2026-04-05
00810199190006ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190013ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24
00810199190020ARKEO, Wedge Fixation SystemAuxano Medical LLCPLF2025-11-24