Patello-Femoral Wave (Kahuna) Arthroplasty System— 510(k) K181280
Substantially EquivalentArthrosurface, Inc.
FDA 510(k) clearance K181280 for Patello-Femoral Wave (Kahuna) Arthroplasty System, Substantially Equivalent on 2018-06-14. Applicant: Arthrosurface, Inc.. Device class: 2.
Clearance details
- Applicant
- Arthrosurface, Inc.
- Product code
- Code KRR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3540
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Franklin, MA, US
Recent devices under product code KRR
view allMore clearances from Arthrosurface, Inc.
view allRecalls naming K181280
K-number listed on FDA's recall record- Z-1045-2023 — MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
- Z-1046-2023 — MEDLINE UNITE FOOT & ANKLE Screw, Polyaxial Locking, Mini T8 (2.0x8mm), REF MMSL2008
- Z-1047-2023 — MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181280.
Data sourced from openFDA. This site is unofficial and independent of the FDA.