Product code HSH— Orthopedic
KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
- Classification name
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
- Device class
- Class 2
- Regulation
- 21 CFR 888.3590
- Advisory panel
- Orthopedic
- Total cleared
- 5
- First cleared
- Most recent
Market context for product code HSH
FDA has cleared devices under product code HSH between 2001 and 2008, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 2006
- 2003
- 2002
- 2001
Top applicants under product code HSH
Recent clearances under product code HSH
- K073233 — ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
- K053094 — ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056
- K033242 — KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
- K022779 — OTI UNICONDULAR INTERPOSITIONAL SPACER
- K003269 — UNICONDYLAR INTERPOSITIONAL SPACER
Data sourced from openFDA. This site is unofficial and independent of the FDA.