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Medshape, Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
1575 NORTHSIDE DR NW STE 440, Atlanta, GA, 30318
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3007593722
DUNS Number
601306413

Catalogue (563)

Page 10 of 12
DeviceModel / ReferenceRegistriesClassStatus
ExoShape 1100-00-1230
FDA UDI
Class IIActive
Ef1 DNE-220-SFC
FDA UDI
Class IIActive
Ef1 DNE-9000-500-CF
FDA UDI
Class IIActive
Ef1 DNE-240-C
FDA UDI
Class IIActive
DynaNail 1200-03-5075
FDA UDI
Class IIActive
DynaNail Mini 2900-22-0078
FDA UDI
Class IActive
DynaClip Forte 3000-06-262020
FDA UDI
Class IIActive
Ef1 DNE-1000-025
FDA UDI
Class IIActive
Acorn Reamer, 7.5mm 2300-01-075
FDA UDI
Class IActive
Ef1 DNE-9000-TH-ST
FDA UDI
Class IActive
DynaNail 2200-16-0000
FDA UDI
Class IActive
Ef1 DNE-50-B
FDA UDI
Class IIActive
DynaNail Hybrid 2601-00-7090
FDA UDI
Class IIActive
DynaClip 3000-05-026
FDA UDI
Class IActive
Profile Drill, 6.5mm, DynaFuse 3100-01-0007
FDA UDI
Class IActive
Ef1 DNE-515045
FDA UDI
Class IIActive
Ef1 DNE-180-OV
FDA UDI
Class IIActive
Parallel Pin Guide, DynaFuse 3100-07-0001
FDA UDI
Class IIActive
DynaClip Quattro 3000-13-000
FDA UDI
Class IActive
Ef1 DNE-6000-038
FDA UDI
Class IIActive
Ef1 DNE-240-34
FDA UDI
Class IIActive
ExoShape 1101-02-000
FDA UDI
Class IActive
Ef1 DNE-35-B
FDA UDI
Class IIActive
ExoShape Femoral 1600-00-009
FDA UDI
Class IIActive
DynaClip Forte 3000-07-030
FDA UDI
Class IActive
DynaNail 1200-02-5040
FDA UDI
Class IIActive
Kitsune 2800-03-015
FDA UDI
Class IActive
DynaClip 3000-14-000
FDA UDI
Class IActive
DynaNail Mini 2600-00-7070
FDA UDI
Class IIActive
DynaNail 2200-10-0000
FDA UDI
Class IActive
Ef1 DNE-6000-035
FDA UDI
Class IIActive
DynaNail Mini 2900-16-070
FDA UDI
Class IActive
Evolve34 3400-11-000
FDA UDI
Class IActive
DynaClip Forte 3000-07-026
FDA UDI
Class IActive
Ef1 DNE-180-SFC
FDA UDI
Class IIActive
DynaNail Mini 2900-05-0002
FDA UDI
Class IActive
DynaNail Helix, Headless, 60mm 3200-01-7060
FDA UDI
Class IIActive
DynaNail Helix, Headed, 70mm 3200-00-7070
FDA UDI
Class IIActive
Ef1 DNE-250-TR
FDA UDI
Class IIActive
DynaNail 2200-13-0030
FDA UDI
Class IActive
ExoShape Teno 1100-01-0920
FDA UDI
Class IIActive
Evolve34 3400-10-000
FDA UDI
Class IActive
DynaNail Mini 2900-03-0225
FDA UDI
Class IActive
DynaNail Mini 2900-07-0000
FDA UDI
Class IActive
DynaNail 1200-01-1030
FDA UDI
Class IIActive
Ef1 DNE-240-DHFP
FDA UDI
Class IIActive
Ef1 DNE-6012-022A
FDA UDI
Class IIActive
DynaClip Quattro 3000-11-181616
FDA UDI
Class IIActive
DynaNail Mini 2900-05-0005
FDA UDI
Class IActive
Ef1 DNE-180-C
FDA UDI
Class IIActive

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Importers

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Authorities

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FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jun 2, 2025Z-2513-2025—open, classified

Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

Nov 17, 2021Z-0453-2022—open, classified

The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.