510(k) K002629
K002629 is an FDA 510(k) premarket notification submitted by Pillar Surgical, Inc. for the device "SILMAX CONTOUR CARVING BLOCK IMPLANT". The FDA issued a decision of Substantially Equivalent on November 20, 2000. The device falls under product code JOF (Polymer, Ent Synthetic, Porous Polyethylene), a Class II device regulated under 21 CFR 874.3620. Pillar Surgical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2000
- Date Received
- August 23, 2000
- 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