FDA.reportPublic FDA data

restor3d Osteotomy Wedge

Primary DI
00840097500300
Brand
restor3d Osteotomy Wedge
Company
Restor3d
Model
1100-ADAS-00-16140407
Device description
Titanium (Ti-6AI-4V ELI) Wedge, Cotton Wedge, Small Footprint, 4mm Thickness
Published
2019-12-16
Public version status
New
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
00840097500300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840097500300008400975003008400975003000840097500300

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

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
00840097502731restor3d Disposable Instrument, Wedge Trial6100-002-221404072021-07-16
00840097502748restor3d Disposable Instrument, Wedge Trial6100-002-221405092021-07-16
00840097502755restor3d Disposable Instrument, Wedge Trial6100-002-221406112021-07-16
00840097502762restor3d Disposable Instrument, Wedge Trial6100-002-221408132021-07-16
00840097502779restor3d Osteotomy Wedge1100-002-221404072021-07-16
00840097502786restor3d Osteotomy Wedge1100-002-221405092021-07-16
00840097502793restor3d Osteotomy Wedge1100-002-221406112021-07-16
00840097502809restor3d Osteotomy Wedge1100-002-221408132021-07-16
00840097500188restor3d Osteotomy Wedge1101-ADAS-00-151606182019-12-16
00840097500195restor3d Osteotomy Wedge1101-ADAS-00-181608182019-12-16
00840097500201restor3d Osteotomy Wedge1101-ADAS-00-181610182019-12-16
00840097500218restor3d Osteotomy Wedge1101-ADAS-00-181612182019-12-16
00840097500225restor3d Osteotomy Wedge1101-ADAS-00-151806182019-12-16
00840097500232restor3d Osteotomy Wedge1101-ADAS-00-201808182019-12-16
00840097500249restor3d Osteotomy Wedge1101-ADAS-00-201810182019-12-16
00840097500256restor3d Osteotomy Wedge1101-ADAS-00-201812182019-12-16
00840097500263restor3d Osteotomy Wedge1101-ADAS-00-152006182019-12-16
00840097500270restor3d Osteotomy Wedge1101-ADAS-00-222008182019-12-16
00840097500287restor3d Osteotomy Wedge1101-ADAS-00-222010182019-12-16
00840097500294restor3d Osteotomy Wedge1101-ADAS-00-222012182019-12-16

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