Stryker 2115 Replacement Battery (2115)
FDA 510(k) K970378 · Implant Resource, Inc.
510(k) numberK970378
Submission
- Device name
- Stryker 2115 Replacement Battery (2115)
- Applicant
- Implant Resource, Inc.
Minneapolis, MN, US - Received
- January 31, 1997
- Decision date
- April 30, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K163308 | SmartoKIJ · Special | Jeil Medical Corporation | 12/27/2016SE |
| K112599 | Insurgical Single Use Power EquipmentKIJ · Traditional | Insurgical, LLC | 11/06/2012SE |
| K101563 | SmartoKIJ · Traditional | Jeil Medical Corporation | 12/17/2010SE |
| K972367 | Stryker System 4000 Heavy Duty Battery Powered EquipmentKIJ · Traditional | Stryker Instruments | 09/04/1997SE |
| K960711 | Acumed Bone Graft SystemKIJ · Traditional | Acu Med, Inc. | 05/07/1996SE |
| K951450 | System 2000 Replacement Battery, System 2000-EXTENDED Run Replacement BatteryKIJ · Traditional | Strenumed, Inc. | 05/17/1995SE |
| K944488 | S & S Orthopedic Wire Driver 701KIJ · Traditional | S & S Orthopedic , Ltd. | 03/02/1995SE |
| K941285 | Arthrex Graft Harvesting KitKIJ · Traditional | Arthrex, Inc. | 11/14/1994SE |
| K933101 | The Osteomed B Power System and AccessoriesKIJ · Traditional | Osteomed Corp. | 11/07/1994SE |
| K933337 | R and D Battery ReplacementKIJ · Traditional | R & D Batteries, Inc. | 04/05/1994SE |
More from R & D Batteries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002125 | Pins and WiresHTY · Traditional | 10/11/2000SE |
Questions and answers
When was Stryker 2115 Replacement Battery (2115) cleared by the FDA?
Stryker 2115 Replacement Battery (2115) (K970378) received a 510(k) decision of Substantially Equivalent on April 30, 1997, 89 days after the submission was received.
What is the product code of K970378?
The FDA product code is KIJ – Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.