HSS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Halter, Head, Traction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.5890
- Medical specialty
- Orthopedic
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1998: 2
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 |
|---|---|---|
| ORTHOPEDIC SOFT GOODS (K771109) | Orthopedic Systems, Inc. | 1977-06-27 |
| MEDISHIELD CERVICAL COLLAR (K770910) | Fraser Sweatman, Inc. | 1977-05-25 |
| SPLIT CERVICAL COLLAR/HEAD HALTER (K760869) | Orthopedic Equipment Co., Inc. | 1976-11-01 |
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Every clearance here is in the API, with alerts when new ones post.