CORE Shoulder System
FDA 510(k) clearance K241470 · decided 2025-02-20
Clearance details
- K-number
- K241470
- Device name
- CORE Shoulder System
- Applicant
- LinkBio Corp.
- Decision
- Substantially Equivalent
- Date received
- 2024-05-24
- Decision date
- 2025-02-20
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- QHE
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Dover, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. recall (Z-1810-2026) | Linkbio Corp. | 2026-04-10 |