510(k) K171037
K171037 is an FDA 510(k) premarket notification submitted by Anatomics Pty, Ltd. for the device "PoreStar Patient Specific Implant". The FDA issued a decision of Substantially Equivalent on December 27, 2017. The device falls under product code JOF (Polymer, Ent Synthetic, Porous Polyethylene), a Class II device regulated under 21 CFR 874.3620. Anatomics Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2017
- Date Received
- April 6, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Polymer, Ent Synthetic, Porous Polyethylene
- Device Class
- Class II
- Regulation Number
- 874.3620
- Review Panel
- EN
- Submission Type