Medshape, Inc.
United StatesFDA applicant, unverified FDA FEI 3007593722
Medshape, Inc. is a medical device manufacturer, with 606 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) and 2 FDA recalls as of 13 Nov 2026.
- Devices
- 606
- Registrations
- FDA
- FDA recalls
- 22 ongoing
Registry facts
- Registries
- FDA GUDID 589
- FDA 510(k) 17
- Device classes
- FDA Class II 362
- FDA Class I 244
- FDA recalls
- Identifiers
- FDA FEI 3007593722
- DUNS 601306413
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Medshape, Inc. makes
Medshape, Inc. manufactures a range of orthopedic surgical devices including single-use external fixation system components, bone-fragment manipulators, non‑distracting intramedullary nails for arthrodesis, non‑bioabsorbable tendon/ligament bone anchors, non‑sliding bone screws, reusable surgical drill guides and cannulated drill bits, as well as non‑adjustable bone staples, with product names such as Kitsune, DynaClip, Quick Connect Handle, Acorn Reamer, EF1, and DynaNail.
Catalogue
Search and filter all 606 devicesShowing 1-50 of 606
Company details
- FDA FEI number
- 3007593722
- DUNS number
- 601306413
- Address
- 1575 NORTHSIDE DR NW STE 440, Atlanta, GA, 30318
FDA recalls
FDA recall records list 2 recalls initiated by Medshape, Inc., the earliest on 2021-11-17 and the most recent on 2025-06-02. By recorded status: 2 ongoing. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 2 Jun 2025 Z-2513-2025 Class II Ongoing 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.
2021
- 17 Nov 2021 Z-0453-2022 Class II Ongoing 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.
Frequently asked questions
How many devices does Medshape, Inc. have in the registry?
The registry currently lists 606 devices for Medshape, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medshape, Inc.'s devices?
Among its 50 most recently registered devices, Medshape, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medshape, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Medshape, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medshape, Inc.?
FDA recall records list 2 recalls initiated by Medshape, Inc., the most recent initiated on 2 Jun 2025. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medshape, Inc. in the registry?
The most recently registered devices listed for Medshape, Inc. include DynaNail 1200-01-1230, DYNANAIL HELIX 3100-13-0001, Active Adaptive 3100-14-0001 and DYNANAIL HELIX 3100-19-0001.