510(k) K971550
- Device
- Kinematic All-polyethylene Patella With Three Pegs
- Applicant
- HOWMEDICA CORP.
- 510(k) number
- K971550
- Product code
- JWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-07-08
- Date received
- 1997-04-28
- Regulation
- 888.3560
- Classification name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- MARGARET F CROWE
- Address
- 359 Veterans Blvd. Rutherford NJ US 07070 07070
FDA Registration Numbers
- 1450662
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Source Documents
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