Product code HTW— Orthopedic
AGEE-WRISTJACK PRE-DRILL KIT
- Classification name
- Bit, Drill
- Device class
- Class 1
- Regulation
- 21 CFR 888.4540
- Advisory panel
- Orthopedic
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code HTW
FDA has cleared devices under product code HTW between 1982 and 2016, 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
- 2016
- 1994
- 1993
- 1992
- 1989
- 1987
- 1986
- 1984
- 1983
- 1982
Top applicants under product code HTW
Adverse events under product code HTW
product code HTW- Injury
- 882
- Malfunction
- 8,544
- Other
- 3
- Total
- 9,429
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 HTW
- K151661 — Renovo Life Hard Carbon Coated Drill Bit
- K942906 — AGEE-WRISTJACK PRE-DRILL KIT
- K930339 — REAMER BIT
- K915692 — CANNULATED DRILL BIT
- K892903 — MITEK ANCHOR DRILL
- K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS
- K863147 — GLENOID DRILL
- K841629 — DRILL BIT
- K834229 — BONE PLUGGING TOOL
- K831712 — SURGICAL DRILL BITS
- K820226 — UNIVERSALL DRILL GUIDE
Data sourced from openFDA. This site is unofficial and independent of the FDA.