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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1575 NORTHSIDE DR NW STE 440, Atlanta, GA, 30318
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007593722
- DUNS Number
- 601306413
Catalogue (563)
Page 3 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ef1 | DNE-2-MP | FDA UDI | Class II | Active |
| Tissue Protector, DynaFuse | 3100-09-0001 | FDA UDI | Class II | Active |
| Eclipse | 1500-01-080 | FDA UDI | Class I | Active |
| DynaClip | 3000-03-014 | FDA UDI | Class I | Active |
| DynaNail Mini | 2600-00-7090 | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-03-4316 | FDA UDI | Class II | Active |
| Ef1 | DNE-1-PL | FDA UDI | Class II | Active |
| DynaClip | 3000-00-182020 | FDA UDI | Class II | Active |
| Ef1 | 1498-000-001 | FDA UDI | Class I | Active |
| Ef1 | DNE-9000-TH-532L | FDA UDI | Class I | Active |
| DynaNail | 1200-02-5030 | FDA UDI | Class II | Active |
| DynaClip | 3000-01-000 | FDA UDI | Class I | Active |
| Eclipse | 1500-00-0920 | FDA UDI | Class II | Active |
| Ef1 | DNE-6000-100L | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-00-7100 | FDA UDI | Class II | Active |
| DynaNail | 2200-30-4031 | FDA UDI | Class I | Active |
| Ef1 | DNE-9000-UJ | FDA UDI | Class II | Active |
| DynaNail Mini | 2900-13-0000 | FDA UDI | Class I | Active |
| Ef1 | DNE-9000-SFR | FDA UDI | Class II | Active |
| DynaNail Mini | 2900-15-0003 | FDA UDI | Class I | Active |
| DynaClip Bone Fixation System, Delta, 32mm x 16mm x 14mm x 12mm | 3000-10-32161412 | FDA UDI | Class II | Active |
| DynaNail Mini | 2600-04-4336 | FDA UDI | Class II | Active |
| Ef1 | 1498-000-002 | FDA UDI | Class I | Active |
| Ef1 | DNE-220-OV | FDA UDI | Class II | Active |
| Ef1 | DNE-312025 | FDA UDI | Class II | Active |
| DynaClip | 3000-00-141414 | FDA UDI | Class II | Active |
| DynaClip | 3000-02-000 | FDA UDI | Class I | Active |
| Ef1 | DNE-1-FP | FDA UDI | Class II | Active |
| DynaClip | 3000-00-202222 | FDA UDI | Class II | Active |
| Ef1 | DNE-1000-HFB | FDA UDI | Class II | Active |
| DynaNail Helix, Headed, 100mm | 3200-00-7100 | FDA UDI | Class II | Active |
| Eclipse | 2300-01-055 | FDA UDI | Class I | Active |
| DynaNail | 1200-01-1226 | FDA UDI | Class II | Active |
| Ef1 | DNE-200-TR | FDA UDI | Class II | Active |
| DynaNail Helix, Headless, 110mm | 3200-01-7110 | FDA UDI | Class II | Active |
| Driver, Quick Connect, Helical Ridge | 2400-02-000 | FDA UDI | Class I | Active |
| Morphix XT | 1000-04-255 | FDA UDI | Class II | Active |
| Eclipse | 2300-01-070 | FDA UDI | Class I | Active |
| Eclipse | 2300-01-060 | FDA UDI | Class I | Active |
| DynaNail Mini | 2900-12-0001 | FDA UDI | Class I | Active |
| Ef1 | DNE-9000-WC | FDA UDI | Class I | Active |
| Morphix XT | 1000-03-245 | FDA UDI | Class II | Active |
| Kitsune | 2800-02-010 | FDA UDI | Class I | Active |
| DynaNail | 2200-18-4031 | FDA UDI | Class I | Active |
| Ef1 | DNE-1000-PW | FDA UDI | Class I | Active |
| Ef1 | DNE-310030 | FDA UDI | Class II | Active |
| Dynanail Mini | 2900-03-0400 | FDA UDI | Class I | Active |
| Ef1 | DNE-410025 | FDA UDI | Class II | Active |
| Ef1 | DNE-220-34 | FDA UDI | Class II | Active |
| DynaNail Helix, Headed, 55mm | 3200-00-7055 | FDA UDI | Class II | Active |
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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.
| 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. |