510(k) DEN220012
- Device
- Tornier Pyrocarbon Humeral Head
- Applicant
- Tornier S.A.S.
- 510(k) number
- DEN220012
- Product code
- QKW
- Decision
- Unknown (DENG)
- Decision date
- 2022-12-16
- Date received
- 2022-02-08
- Regulation
- 888.3695
- Classification name
- Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- Loucinda Bjorklund
- Address
- 161 Rue Lavoisier Montbonnot-Saint-Martin FR 38330 38330
FDA Registration Numbers#
- 3000931034
- 3008388276
- 3002807295
- 3010178296
- 3003902387
Source Documents#
510(k) summary PDF not indicated by FDA