Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
FDA 510(k) clearance K233527 · decided 2023-11-29
Clearance details
- K-number
- K233527
- Device name
- Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
- Applicant
- Spinal Simplicity, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-11-01
- Decision date
- 2023-11-29
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- PEK
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Overland Park, KS, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.