PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
FDA 510(k) clearance K090075 · decided 2009-03-06
Clearance details
- K-number
- K090075
- Device name
- PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
- Applicant
- Parcus Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-01-12
- Decision date
- 2009-03-06
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sturgeon Bay, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.