Data / Medical devices / United States / Medshape, Inc.
Medshape, Inc.: FDA-registered device maker in Atlanta, GA, United States, 17 510(k) clearances
Medshape, Inc. is registered with the FDA (registration 3007593722) in Atlanta, GA, United States. It lists 15 device types. The FDA files 17 510(k) clearances under its listings, the newest dated September 23, 2026. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007593722
- Address
- 1575 Northside DR NW Ste 440, Atlanta, GA, United States, 30318
- Owner or operator
- MedShape, Incorporated (10026693)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 14, 2009
- Registered through
- 2027
- Brand names listed
- Bone Punch, Disposable Drill and Drill Guide Procedure Pack, Drills and Drill Guides, DynaClip Delta Bone Staple, DynaClip Quattro Bone Staple, DynaFuse Fixation System, DynaNail, DynaNail Ankle Arthrodesis Intramedullary Nail and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Kit, Surgical Instrument, Disposable | KDD | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nail, Fixation, Bone | JDS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 23, 2026 | K260995 | DynaNail Helix® Fixation System | HWC | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| September 12, 2025 | K250628 | DynaNail TTC Fusion System | HSB | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| August 19, 2022 | K220812 | DynaClip® Bone Staple | JDR | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| January 4, 2022 | K203595 | DynaFuse Fixation System | HWC | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| January 15, 2021 | K203381 | Dynanail Mini Hybrid | HWC | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| April 23, 2020 | K193305 | DynaClip Bone Staple | JDR | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| February 14, 2019 | K182677 | DynaNail Mini | HWC | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| November 5, 2018 | K181781 | DynaClipTM Bone Staple | JDR | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| November 2, 2017 | K171376 | DynaNail TTC Fusion System | HSB | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| February 16, 2016 | K151580 | D.N.E. External Fixation System | KTT | Substantially Equivalent | Dne, LLC | accessdata.fda.gov |
| May 29, 2014 | K140158 | S.E.A.L. FRACTURE FUSION TUBE | KTT | Substantially Equivalent | Dne, LLC | accessdata.fda.gov |
| March 7, 2013 | K123350 | ECLIPSE SOFT TISSUE FASTENER | MBI | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| February 29, 2012 | K113828 | DYNANAIL ANKLE ARTHRODESIS NAIL | HSB | Substantially Equivalent | MedShape, Inc. | accessdata.fda.gov |
| January 4, 2012 | K113106 | DNE EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Dne, LLC | accessdata.fda.gov |
| August 3, 2011 | K101934 | DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 | HSB | Substantially Equivalent | Medshape Solutions | accessdata.fda.gov |
| December 9, 2009 | K092914 | WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES | MBI | Substantially Equivalent | Medshape Solutions | accessdata.fda.gov |
| September 16, 2009 | K091202 | WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS, | HWC | Substantially Equivalent | Medshape Solutions | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| June 2, 2025 | 97064 | Class II | Ongoing | Medshape Universal Joints, REF: DNE-9000-UJ | 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. | accessdata.fda.gov |
| November 17, 2021 | 89117 | Class II | Ongoing | DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile | 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. | accessdata.fda.gov |
| April 4, 2013 | 64988 | Class II | Terminated | ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone. | Expiration date on the patient label and date on the product carton were not the same. | accessdata.fda.gov |
Compare with other makers
- All makers of Staple, Fixation, Bone
- All makers of Washer, Bolt Nut
- All makers of Screw, Fixation, Bone
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.