Product code HTO— Orthopedic
ABC-1000 SMALL JOINT REAMERS
- Classification name
- Reamer
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Total cleared
- 14
- First cleared
- Most recent
Market context for product code HTO
FDA has cleared devices under product code HTO between 1977 and 2011, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2011
- 2005
- 2001
- 2000
- 1995
- 1990
- 1989
- 1987
- 1986
- 1983
- 1981
- 1979
- 1977
Top applicants under product code HTO
Adverse events under product code HTO
product code HTO- Injury
- 404
- Malfunction
- 20,305
- Total
- 20,709
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 →
Recent clearances under product code HTO
- K111437 — SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
- K042899 — SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
- K013527 — MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
- K993335 — SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
- K954915 — FLEXIBLE INTRAMEDULLARY REAMER
- K903248 — COMBINATION REAMER
- K885100 — MCCONNELL REAMER GUIDE
- K870845 — WARSAW ORTHOPEDIC POINTED REAMER
- K862933 — ABC-1000 SMALL JOINT REAMERS
- K832686 — MULTIPLE MANUAL SURGICAL INSTRUMENTS
- K811081 — MEDULLARY CANAL SCRAPERS
- K790996 — C.C.F. FEMORAL DEBRIDEMENT PROBE
- K790307 — FLEXIBLE REAMER, GUIDE WIRE SYSTEM
- K770203 — HAND REAMERS
Data sourced from openFDA. This site is unofficial and independent of the FDA.