TheRay Collared and Collarless Femoral Stem
FDA 510(k) clearance K241875 · decided 2024-09-13
Clearance details
- K-number
- K241875
- Device name
- TheRay Collared and Collarless Femoral Stem
- Applicant
- Nextstep Arthropedix
- Decision
- Substantially Equivalent
- Date received
- 2024-06-28
- Decision date
- 2024-09-13
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MEH
- Device class
- 2
- Regulation number
- 888.3353
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Hea recall (Z-0227-2026) | Theken Companies LLC | 2025-10-21 |