510(k) K890185
- Device
- C-S IMPACTOR
- Applicant
- ORTHOPEDIC SYSTEMS, INC.
- 510(k) number
- K890185
- Product code
- LYP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-06
- Date received
- 1989-01-18
- Regulation
- 888.3050
- Classification name
- Accessories, Fixation, Spinal Interlaminal
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT R MOORE
- Address
- 1897 National Ave. Hayward CA US 94545 94545
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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