Knee Prosthesis Driver
FDA 510(k) K915776 · Kim-Med, Inc.
510(k) numberK915776
Submission
- Device name
- Knee Prosthesis Driver
- Applicant
- Kim-Med, Inc.
Kansas City, MO, US - Received
- December 24, 1991
- Decision date
- June 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HWR – Driver, Prosthesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4540
- Specialty
- Orthopedic
Other 510(k)s with product code HWR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K875054 | Acromed Ads Bone Nail DriverHWR · Traditional | Buckman Co., Inc. | 01/28/1988SE |
| K870848 | Schultz Metacarpal Component DriverHWR · Traditional | Warsaw Orthopedic, Inc. | 03/13/1987SE |
| K870847 | Schultz Phalangeal Component DriverHWR · Traditional | Warsaw Orthopedic, Inc. | 03/13/1987SE |
Questions and answers
When was Knee Prosthesis Driver cleared by the FDA?
Knee Prosthesis Driver (K915776) received a 510(k) decision of Substantially Equivalent on June 11, 1992, 170 days after the submission was received.
What is the product code of K915776?
The FDA product code is HWR – Driver, Prosthesis, a Class I (low risk) device regulated under 21 CFR 888.4540.