STRYKER 2115 REPLACEMENT BATTERY (2115)
FDA 510(k) clearance K970378 · decided 1997-04-30
Clearance details
- K-number
- K970378
- Device name
- STRYKER 2115 REPLACEMENT BATTERY (2115)
- Applicant
- Implant Resource, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-01-31
- Decision date
- 1997-04-30
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- KIJ
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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| S & S ORTHOPEDIC WIRE DRIVER 701 (K944488) | S & S Orthopedic , Ltd. | 1995-03-02 |
| ARTHREX GRAFT HARVESTING KIT (K941285) | Arthrex, Inc. | 1994-11-14 |
| THE OSTEOMED B POWER SYSTEM AND ACCESSORIES (K933101) | Osteomed Corp. | 1994-11-07 |
| R AND D BATTERY REPLACEMENT (K933337) | R & D Batteries, Inc. | 1994-04-05 |
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Recalls involving this device
No recalls on record reference this clearance.