RemeOs™ Screw LAG Solid
FDA 510(k) clearance DEN220030 · decided 2023-03-29
Clearance details
- K-number
- DEN220030
- Device name
- RemeOs™ Screw LAG Solid
- Applicant
- Bioretec, Ltd.
- Decision
- Unknown
- Date received
- 2022-05-04
- Decision date
- 2023-03-29
- Days to decision
- 329 days
- Clearance type
- Direct
- Product code
- QJD
- Device class
- 2
- Regulation number
- 888.3041
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Tampere, FI
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bioretec
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.
Recalls involving this device
No recalls on record reference this clearance.