The following data is part of a premarket notification filed by Implant Resource, Inc. with the FDA for Stryker 2115 Replacement Battery (2115).
| Device ID | K970378 |
| 510k Number | K970378 |
| Device Name: | STRYKER 2115 REPLACEMENT BATTERY (2115) |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | IMPLANT RESOURCE, INC. 11975 PORTLAND AVENUE S. SUITE 138 Minneapolis, MN 55337 |
| Contact | Michael Holloway |
| Correspondent | Michael Holloway IMPLANT RESOURCE, INC. 11975 PORTLAND AVENUE S. SUITE 138 Minneapolis, MN 55337 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-31 |
| Decision Date | 1997-04-30 |