Is this your brand? Sign in to claim ownership.

Medshape, Inc.

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 11 of 12

Device	Model / Reference	Registries	Class	Status
DynaNail Mini	2600-04-4334	FDA UDI	Class II	Active
Ef1	DNE-200-OV	FDA UDI	Class II	Active
DynaNail Helix, Headed, 110mm	3200-00-7110	FDA UDI	Class II	Active
DynaClip	3000-00-262020	FDA UDI	Class II	Active
Ef1	DNE-220-SFU	FDA UDI	Class II	Active
DynaNail Mini	2900-02-0650	FDA UDI	Class I	Active
Morphix XT	1000-04-245	FDA UDI	Class II	Active
DynaNail	2200-08-0040	FDA UDI	Class I	Active
Ef1	DNE-200-C	FDA UDI	Class II	Active
Ef1	DNE-240-OV	FDA UDI	Class II	Active
Ef1	DNE-240-5	FDA UDI	Class II	Active
Ef1	DNE-220-5	FDA UDI	Class II	Active
Ef1	DNE-9000-RW	FDA UDI	Class II	Active
Ef1	DNE-618035	FDA UDI	Class II	Active
DynaNail Helix, Headed, 85mm	3200-00-7085	FDA UDI	Class II	Active
Ef1	DNE-9010-100L	FDA UDI	Class I	Active
Ef1	DNE-2-PL	FDA UDI	Class II	Active
Ef1	DNE-6000-200	FDA UDI	Class II	Active
DynaNail Removal Tool, Detensioning Wrench	2200-25-0000	FDA UDI	Class I	Active
Reusable Drill Guide Assembly, T-Shape, DynaClip, 8mm	3000-05-008	FDA UDI	Class I	Active
Ef1	DNE-160-DXFP	FDA UDI	Class II	Active
Ef1	DNE-180-SFU	FDA UDI	Class II	Active
Reusable Drill Guide Assembly, T-Shape, DynaClip, 10mm	3000-05-010	FDA UDI	Class I	Active
Ef1	6206-0002200-00	FDA UDI	Class I	Active
Ef1	753-000-001	FDA UDI	Class I	Active
Ef1	F4-156180	FDA UDI	Class II	Active
Ef1	DNE-9000-400-CF	FDA UDI	Class II	Active
Ef1	DNE-160-5	FDA UDI	Class II	Active
Ef1	DNE-6012-021A	FDA UDI	Class II	Active
ExoShape Femoral	1600-00-010	FDA UDI	Class II	Active
Instrument Tray, CF, DynaNail	2200-20-0001	FDA UDI	Class I	Active
Evolve34	3400-19-000	FDA UDI	Class I	Active
Instrument Tray, DynaFuse	3100-11-0001	FDA UDI	Class I	Active
Ef1	DNE-140-34	FDA UDI	Class II	Active
Clamp T Handle (Black) with 5/32 tool shaft	DNE-9000-TH-532	FDA UDI	Class II	Active
Evolve34	3400-06-001	FDA UDI	Class I	Active
Ef1	DNE-6012-020A	FDA UDI	Class II	Active
Joint Finder Fulcrum, Right	3400-08-000	FDA UDI	Class I	Active
Ef1	DNE-9000-300-PTB	FDA UDI	Class II	Active
DynaNail Helix, Headless, 50mm	3200-01-7050	FDA UDI	Class II	Active
ExoShape Teno	1100-01-0820	FDA UDI	Class II	Active
DynaNail Helix, Headed, 75mm	3200-00-7075	FDA UDI	Class II	Active
Ef1	DNE-120-DHFP	FDA UDI	Class II	Active
Ef1	DNE-1-MP	FDA UDI	Class II	Active
Ef1	DNE-200-SFU	FDA UDI	Class II	Active
DynaNail Helix, Headed, 65mm	3200-00-7065	FDA UDI	Class II	Active
Ef1	DNE-9000-WS	FDA UDI	Class II	Active
DynaFuse Fixation System	K203595	FDA 510(k)	Class II	Active
DynaNail Mini Tapered Hybrid	K240530	FDA 510(k)	Class II	Active
DynaClipTM Bone Staple	K181781	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.

Date	Recall No.	Class	Status	Reason
Jun 2, 2025	Z-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, 2021	Z-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.