510(k) K181532
K181532 is an FDA 510(k) premarket notification submitted by Exactech, Inc. for the device "Exactech Alteon Monobloc Revision Stem". The FDA issued a decision of Substantially Equivalent on Sep 4, 2018. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Exactech, Inc. has 185 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 4, 2018
- Date Received
- Jun 11, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type
- 510(k)