510(k) K221333 ยท HWC Screw, Fixation, Bone
Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Dec 29, 2022 |
| Received | May 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221333
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2022 | Acumed LLC Part Number/Part Description:
30-0033-S 30mm Acutrak Fusion Device 6mm Nose
AM-0025-S 25.0mm Acutrak 4/5 Bone Screw
AM-0030-S 30.0mm Acutrak 4/5 Bone Screw
AM-0035-S 35.0mm Acutrak 4/5 Bone Open, Classified |
HWC | None listed |
| Dec 23, 2022 | Acumed LLC Acutrak 2
Part Number/Part Description:
30-0021 25.0mm Acutrak 2 - 5.5 Screw
30-0021-S 25.0mm Acutrak 2 - 5.5 Screw
30-0023 30.0mm Acutrak 2 - 5.5 Screw
30-0023-S 30.0mm Acutrak 2 - 5.5 Screw
30-0025 Open, Classified |
HWC | None listed |
| Dec 23, 2022 | Acumed LLC AcuTwist Acutrak Compression Screws
Part Number/Part Description:
AI-0010-S 10mm AcuTwist Acutrak Compression Screw
AI-0012-S 12mm AcuTwist Acutrak Compression Screw
AI-0014-S 14mm AcuTwist Acutrak Co Open, Classified |
HWC | None listed |
| Dec 23, 2022 | Acumed LLC Dual-Trak Clavicle Screws
Part Number/Part Description:
40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw
40-0 Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.