K970378 is an FDA 510(k) clearance for the STRYKER 2115 REPLACEMENT BATTERY (2115). This device is classified as a Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (Class I - General Controls, product code KIJ).
Submitted by Implant Resource, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 30, 1997, 89 days after receiving the submission on January 31, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 878.4820.
| 510(k) Number | K970378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1997 |
| Decision Date | April 30, 1997 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KIJ — Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4820 |