510(k) clearance
Tempo Plating System; Ultra Compression Screw System
- 510(k) number
- K261647
- Applicant
- Pace Surgical
- Decision date
- Sep 3, 2026
- Date received
- May 19, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HRS
- Device type
- Plate, Fixation, Bone
- Device class
- Class II
- Regulation
- 21 CFR 888.3030
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Malvern, PA, US