HXK
5 FDA 510(k) clearances · Product code
25 daysmedian time to decision
57 days90th percentile
5clearances measured
FDA profile
- Official device name
- Holder, Needle; Orthopedic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Medical specialty
- Orthopedic
- Adverse events (MAUDE)
- 1992: 1 · 2006: 5 · 2007: 2 · 2020: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HOLDER, NEEDLE (K890167) | Dhason Brothers, Inc. | 1989-02-03 |
| MICRINS NEEDLE HOLDER (K872989) | Micrins Surgical, Inc. | 1987-08-21 |
| FISCHER WIRE/PIN CLAMP (K860018) | Buckman Co., Inc. | 1986-02-07 |
| ACE FISCHER EXTERNAL FIXATION DEVICE (K801594) | Ace Orthopedic Manufacturing Co. | 1980-09-09 |
| CONVERSE-GILLIES NEEDLE HOLDER (K772388) | Edward Weck, Inc. | 1978-01-20 |
Track HXK automatically
Every clearance here is in the API, with alerts when new ones post.