510(k) DEN220030
- Device
- RemeOs™ Screw LAG Solid
- Applicant
- Bioretec, Ltd.
- 510(k) number
- DEN220030
- Product code
- QJD
- Decision
- Unknown (DENG)
- Decision date
- 2023-03-29
- Date received
- 2022-05-04
- Regulation
- 888.3041
- Classification name
- Absorbable Metallic Bone Fixation Fastener
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mari Ruotsalainen
- Address
- Yrittäjänkulma 5 Tampere FI FI-33710 FI-33710
FDA Registration Numbers#
- 3005536892
Source Documents#
510(k) summary PDF not indicated by FDA