K780226 is an FDA 510(k) clearance for the SPREADER BARS. This device is classified as a Accessories, Traction (Class I - General Controls, product code ILZ).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 17, 1978, 8 days after receiving the submission on February 9, 1978.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5925.
| 510(k) Number | K780226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1978 |
| Decision Date | February 17, 1978 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILZ — Accessories, Traction |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5925 |