BEAR® (Bridge-Enhanced ACL Restoration) Implant— 510(k) K243578
Substantially EquivalentMiach Orthopaedics, Inc.
FDA 510(k) clearance K243578 for BEAR® (Bridge-Enhanced ACL Restoration) Implant, Substantially Equivalent on 2025-03-06. Applicant: Miach Orthopaedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Miach Orthopaedics, Inc.
- Product code
- Code QNI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3044
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westborough, MA, US
Recent devices under product code QNI
view allRecalls naming K243578
K-number listed on FDA's recall record- Z-1220-2026 — BEAR Implant. Model Number: 1000.
- Z-0479-2026 — BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243578.
Data sourced from openFDA. This site is unofficial and independent of the FDA.