MAX ADJUSTING INSTRUMENT
FDA 510(k) clearance K082218 · decided 2008-08-13
Clearance details
- K-number
- K082218
- Device name
- MAX ADJUSTING INSTRUMENT
- Applicant
- Manna Omni International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-06
- Decision date
- 2008-08-13
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- LXM
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Fullerton, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Manna Omni International
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.
Recalls involving this device
No recalls on record reference this clearance.