510(k) K864490
- Device
- SWANSON TITANIUM CARPAL SCAPHOID IMPLANT
- Applicant
- DOW CORNING WRIGHT
- 510(k) number
- K864490
- Product code
- KWO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-04-15
- Date received
- 1986-11-13
- Regulation
- 888.3760
- Classification name
- Prosthesis, Wrist, Carpal Scaphoid
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANTHONY J LENTZ
- Address
- P.O. Box 100 Arlington TN US 38002 38002
FDA Registration Numbers#
- 3004154314
- 3010667733
- 1043534
- 1450662
- 1828288
- 1825034
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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