SLED UNICOMPARTMENT KNEE SYSTEM
FDA 510(k) clearance K954186 · decided 1996-01-26
Clearance details
- K-number
- K954186
- Device name
- SLED UNICOMPARTMENT KNEE SYSTEM
- Applicant
- Link America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-09-06
- Decision date
- 1996-01-26
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- HSX
- Device class
- 2
- Regulation number
- 888.3520
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- East Hanavor, NJ, US
- Third-party review
- No
- Expedited review
- No
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