CONGRUENT BONE PLATE SYSTEM
FDA 510(k) clearance K012655 · decided 2001-11-07
Clearance details
- K-number
- K012655
- Device name
- CONGRUENT BONE PLATE SYSTEM
- Applicant
- Acu Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2001-11-07
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- HRS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beaverton, OR, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Acu Med
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.