BONE PLATE
FDA 510(k) clearance K870082 · decided 1987-05-06
Clearance details
- K-number
- K870082
- Device name
- BONE PLATE
- Applicant
- Terray Manufacturing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-08
- Decision date
- 1987-05-06
- Days to decision
- 118 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ontario K7s 1l8, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.