Klassic Infection Spacer System— 510(k) K261734
Substantially EquivalentTotal Joint Orthopedics, Inc.
FDA 510(k) clearance K261734 for Klassic Infection Spacer System, Substantially Equivalent on 2026-07-23. Applicant: Total Joint Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Total Joint Orthopedics, Inc.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code JWH
view allMore clearances from Total Joint Orthopedics, Inc.
view all- K220483 — Platform® Acetabular System
- K211877 — Klassic Knee System
- K211602 — Klassic Knee System
- K202740 — Klassic Knee System Tibial Inserts, PS-Max
- K183596 — Klassic Knee System - Klassic Knee PS-Post Femur; Klassic Knee Tibial Insert, PS-Post, Std Poly; Klassic Knee Tibial Insert, PS-Post, E-Link Poly
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.