Fix2Lock (PEEK Self Punching)
FDA 510(k) clearance K202763 · decided 2021-06-04
Clearance details
- K-number
- K202763
- Device name
- Fix2Lock (PEEK Self Punching)
- Applicant
- Osteonic Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-21
- Decision date
- 2021-06-04
- Days to decision
- 256 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Guro-Gu, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osteonic Co.
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.