K895172 is an FDA 510(k) clearance for the KRONNER SACRAL PIN GUIDE. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Kronner Medical (Roseburg, US). The FDA issued a Cleared decision on September 12, 1989, 33 days after receiving the submission on August 10, 1989.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K895172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1989 |
| Decision Date | September 12, 1989 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LXH — Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |