PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
FDA 510(k) clearance K082267 · decided 2008-10-29
Clearance details
- K-number
- K082267
- Device name
- PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-11
- Decision date
- 2008-10-29
- Days to decision
- 79 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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