E3D-A Interbody System

HAnano STATIC Ti ALIF 40 X 28mm 15deg 21mm (P 13mm)

Registry build 21.09.26
1manufacturer
308catalogue numbers in this listing

Who Else Makes It

Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PHM
Manufacturer City Province Registered as Device types
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42

Record

Regulatory record for E3D-A Interbody System
Listed by Evolution Spine, LLC, United States
FDA product code PHM
Device type Intervertebral Fusion Device With Bone Graft, Thoracic
Device class Class 2
Regulation 21 CFR 888.3080
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k) K223146
Record published 2023-03-15
Record revised 2024-09-11 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number
Sizes Depth 24 to 28 mm; height 9 to 21 mm; angle 8 to 30 °; width 32 to 40 mm; length 20 to 35 mm; outer diameter 5.5 to 6 mm

Catalogue Numbers

Catalogue numbers for E3D-A Interbody System
Catalogue number Size Status
111G-M2520 Depth 26 mm In distribution
110G-L1519 Depth 28 mm In distribution
110H-55VB20-3 In distribution
110H-L2017 Height 17 mm In distribution
111G-S2516 Width 32 mm In distribution
110G-M2018 Width 36 mm In distribution
111H-L1521 Width 40 mm In distribution
110G-M2521 Depth 26 mm In distribution
111G-L2020 Height 20 mm In distribution
110H-ML1520 Depth 28 mm In distribution
111H-L1520 Depth 28 mm In distribution
110G-M1520 Width 36 mm In distribution
110G-S3017 Depth 24 mm In distribution
111H-S2013 Height 13 mm In distribution
110G-L0812 Width 40 mm In distribution
111H-M2017 Depth 26 mm In distribution
110G-ML0819 Height 19 mm In distribution
111H-ML2016 Width 38 mm In distribution
110G-S1518 Depth 24 mm In distribution
111G-L1515 Width 40 mm In distribution
110G-ML2520 Angle 25 ° In distribution
111G-M1518 Depth 26 mm In distribution
111G-L2019 Angle 20 ° In distribution
111G-M0811 Width 36 mm In distribution
111G-S2020 Angle 20 ° In distribution
110-55VT30 Length 30 mm In distribution
111H-ML0810 Width 38 mm In distribution
110H-M1519 Width 36 mm In distribution
110-60FT35 Length 35 mm In distribution
111H-M1521 Width 36 mm In distribution
110G-M1516 Angle 15 ° In distribution
111G-M1515 Width 36 mm In distribution
111H-M2014 Angle 20 ° In distribution
110G-ML1518 Width 38 mm In distribution
110H-60FB20-3 In distribution
110H-L2520 Angle 25 ° In distribution
111H-ML0817 Angle 8 ° In distribution
110G-ML2013 Angle 20 ° In distribution
111H-M2515 Width 36 mm In distribution
110H-60FT35-2 In distribution
110H-60FB25-2 In distribution
110H-ML0811 Depth 28 mm In distribution
111H-L1512 Width 40 mm In distribution
110H-L1519 Depth 28 mm In distribution
111H-M2021 Angle 20 ° In distribution
110H-M1512 Width 36 mm In distribution
110G-ML1520 Depth 28 mm In distribution
110G-ML1512 Height 12 mm In distribution
111G-L0814 Depth 28 mm In distribution
110H-L1515 Depth 28 mm In distribution
110G-ML2519 Angle 25 ° In distribution
111H-ML2520 Height 20 mm In distribution
110H-S3021 Width 32 mm In distribution
110G-ML1516 Height 16 mm In distribution
111H-S2014 Angle 20 ° In distribution
111H-S2021 Height 21 mm In distribution
110H-L0813 Depth 28 mm In distribution
111H-S2521 Depth 24 mm In distribution
110G-M3017 Depth 26 mm In distribution
110H-60FB20 In distribution
110G-ML2515 Width 38 mm In distribution
110G-S2014 Width 32 mm In distribution
111H-M1514 Width 36 mm In distribution
110H-55VB30-2 In distribution
111G-L2018 Depth 28 mm In distribution
111H-ML2519 Depth 28 mm In distribution
111G-L2013 Height 13 mm In distribution
111H-M0813 Angle 8 ° In distribution
111G-S1519 Height 19 mm In distribution
111H-L1517 Width 40 mm In distribution
111G-S3021 Depth 24 mm In distribution
110G-L1516 Depth 28 mm In distribution
110G-M2014 Depth 26 mm In distribution
111H-ML3021 Depth 28 mm In distribution
111G-L2519 Height 19 mm In distribution
110G-S1515 Width 32 mm In distribution
110H-ML0817 Width 38 mm In distribution
110H-S0815 Height 15 mm In distribution
111H-S3020 Width 32 mm In distribution
111H-L3018 Height 18 mm In distribution
111H-M2018 Angle 20 ° In distribution
110G-ML3018 Depth 28 mm In distribution
110H-S3017 Width 32 mm In distribution
110G-S2515 Depth 24 mm In distribution
110H-55VB25 In distribution
110H-60FT25-2 In distribution
110G-M2518 Depth 26 mm In distribution
110H-60FB35-2 In distribution
110H-ML1517 Height 17 mm In distribution
110H-S1511 Height 11 mm In distribution
110H-S0820 Depth 24 mm In distribution
111G-ML0820 Angle 8 ° In distribution
110G-S0821 Height 21 mm In distribution
111G-ML1519 Width 38 mm In distribution
111G-L3021 Width 40 mm In distribution
111G-M0820 Height 20 mm In distribution
111G-ML2518 Height 18 mm In distribution
110H-55VT20 In distribution
110H-M0812 Width 36 mm In distribution
110H-L1511 Angle 15 ° In distribution
111G-L0809 Height 9 mm In distribution
111G-ML3018 Angle 30 ° In distribution
110H-ML0821 Depth 28 mm In distribution
110H-S0811 Angle 8 ° In distribution
111G-ML0812 Angle 8 ° In distribution
110G-M0813 Angle 8 ° In distribution
110H-55VT25 In distribution
110H-M1514 Depth 26 mm In distribution
111H-L0809 Height 9 mm In distribution
110H-55VB30-3 In distribution
111H-S0811 Angle 8 ° In distribution
110G-S2021 Angle 20 ° In distribution
110-60FT25 Outer Diameter 6 mm In distribution
110G-ML0814 Width 38 mm In distribution
111H-M0811 Height 11 mm In distribution
110H-60FB35-3 In distribution
111G-M2519 Depth 26 mm In distribution
111G-M0817 Height 17 mm In distribution
110H-55VB20-2 In distribution
111H-L2017 Height 17 mm In distribution
111H-ML3017 Depth 28 mm In distribution
110H-55VB30 In distribution
110G-ML2019 Height 19 mm In distribution
111G-S3017 Angle 30 ° In distribution
111G-ML3017 Depth 28 mm In distribution
111H-ML0814 Height 14 mm In distribution
110H-S0814 Width 32 mm In distribution
110H-L1514 Width 40 mm In distribution
111G-L1511 Depth 28 mm In distribution
110G-M3018 Depth 26 mm In distribution
111G-M2013 Angle 20 ° In distribution
111H-S1519 Width 32 mm In distribution
110H-ML0812 Width 38 mm In distribution
111G-M3020 Angle 30 ° In distribution
110G-S2017 Height 17 mm In distribution
111H-M0817 Height 17 mm In distribution
111G-L1516 Depth 28 mm In distribution
111H-L2021 Depth 28 mm In distribution
110G-S1520 Height 20 mm In distribution
110H-M2519 Angle 25 ° In distribution
110G-L1512 Angle 15 ° In distribution
111G-S1518 Width 32 mm In distribution
110G-ML3021 Angle 30 ° In distribution
111G-ML3019 Width 38 mm In distribution
111H-L3019 Height 19 mm In distribution
111G-M1516 Height 16 mm In distribution
110G-M1512 Angle 15 ° In distribution
110H-L2519 Width 40 mm In distribution
110G-S2521 Depth 24 mm In distribution
111G-S0818 Angle 8 ° In distribution
110G-L0819 Height 19 mm In distribution
110H-55VT25-2 In distribution
111G-S3020 Angle 30 ° In distribution
110H-S2521 Depth 24 mm In distribution
111G-M2017 Width 36 mm In distribution
111G-L2520 Height 20 mm In distribution
110G-L2515 Depth 28 mm In distribution
110G-ML0817 Height 17 mm In distribution
110G-L2516 Height 16 mm In distribution
110H-M0811 Depth 26 mm In distribution
111H-L0821 Height 21 mm In distribution
110H-ML2518 Width 38 mm In distribution
110G-L3021 Depth 28 mm In distribution
110G-ML1519 Height 19 mm In distribution
110G-M1521 Width 36 mm In distribution
110G-L2014 Depth 28 mm In distribution
110H-M1518 Height 18 mm In distribution
111H-M0818 Width 36 mm In distribution
111H-M1516 Width 36 mm In distribution
111G-S2021 Width 32 mm In distribution
110H-55VT35-2 In distribution
110G-ML0818 Width 38 mm In distribution
110G-M3020 Height 20 mm In distribution
111G-S3018 Width 32 mm In distribution
110G-M3019 Depth 26 mm In distribution
110H-L1512 Width 40 mm In distribution
110H-60FT40-3 In distribution
110G-S3018 Angle 30 ° In distribution
110H-S1521 Width 32 mm In distribution
111G-M0814 Angle 8 ° In distribution
110G-M2520 Depth 26 mm In distribution
111H-M1518 Height 18 mm In distribution
110H-S0812 Width 32 mm In distribution
110H-ML2021 Width 38 mm In distribution
110G-M2013 Width 36 mm In distribution
111G-ML0811 Depth 28 mm In distribution
111H-S0812 Angle 8 ° In distribution
110-55VB20 Outer Diameter 5.5 mm In distribution
111G-ML0814 Width 38 mm In distribution
111G-M2016 Height 16 mm In distribution
110H-ML1513 Height 13 mm In distribution
111H-ML2515 Width 38 mm In distribution
111G-S2014 Angle 20 ° In distribution
110G-ML2016 Height 16 mm In distribution
110H-ML1516 Depth 28 mm In distribution
111H-M2521 Depth 26 mm In distribution
111G-S1512 Height 12 mm In distribution
111H-ML0818 Depth 28 mm In distribution
111G-ML0817 Width 38 mm In distribution
111G-L2015 Depth 28 mm In distribution
111G-S1517 Height 17 mm In distribution
111H-S1515 Angle 15 ° In distribution
111H-ML0813 Width 38 mm In distribution
110G-S2016 Depth 24 mm In distribution
110H-ML1518 Width 38 mm In distribution
111G-S1514 Width 32 mm In distribution
110-60FB30 Outer Diameter 6 mm In distribution
111G-ML0819 Height 19 mm In distribution
111G-S0816 Depth 24 mm In distribution
110G-M2015 Width 36 mm In distribution
110H-M1511 Width 36 mm In distribution
111H-S0816 Width 32 mm In distribution
111H-ML3019 Height 19 mm In distribution
111H-L0815 Angle 8 ° In distribution
111G-M0816 Height 16 mm In distribution
111H-L2020 Angle 20 ° In distribution
111H-L0820 Depth 28 mm In distribution
110G-ML2015 Angle 20 ° In distribution
110G-L2017 Depth 28 mm In distribution
111G-ML2520 Width 38 mm In distribution
110G-S0815 Angle 8 ° In distribution
110H-ML0814 Angle 8 ° In distribution
111G-ML1512 Angle 15 ° In distribution
111H-ML2015 Height 15 mm In distribution
110H-55VT30-3 In distribution
110-60FB20 Outer Diameter 6 mm In distribution
110H-60FB25-3 In distribution
110H-S1515 Width 32 mm In distribution
111H-ML0815 Width 38 mm In distribution
111G-L3020 Angle 30 ° In distribution
110H-ML1512 Width 38 mm In distribution
111G-ML2014 Depth 28 mm In distribution
110H-M1516 Width 36 mm In distribution
110H-55VB25-3 In distribution
110H-S0813 Angle 8 ° In distribution
111G-S2521 Height 21 mm In distribution
110H-ML2014 Height 14 mm In distribution
110H-ML2013 Width 38 mm In distribution
111G-M2021 Width 36 mm In distribution
111G-ML0818 Depth 28 mm In distribution
111G-ML2516 Angle 25 ° In distribution
110H-L1516 Depth 28 mm In distribution
110H-60FB25 In distribution
111G-L0819 Height 19 mm In distribution
111H-ML3018 Depth 28 mm In distribution
111H-L2015 Width 40 mm In distribution
111H-L1515 Depth 28 mm In distribution
110G-M1515 Height 15 mm In distribution
111H-M1513 Depth 26 mm In distribution
110H-55VT20-2 In distribution

Showing 250 of 300 catalogue numbers.

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Showing 12 of 41. All products under Intervertebral Fusion Device With Bone Graft, Thoracic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

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