PERMARIDGE HYDROXYLAPATITE MATRIX
FDA 510(k) clearance K960349 · decided 1996-03-13
Clearance details
- K-number
- K960349
- Device name
- PERMARIDGE HYDROXYLAPATITE MATRIX
- Applicant
- Ceramed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-25
- Decision date
- 1996-03-13
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- FWP
- Device class
- 2
- Regulation number
- 878.3550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PEPGEN P-15 FLOW (P990033/S017) | Ceramed Corp. | 2010-07-20 |
| PEPGEN P-15 FLOW (P990033/S016) | Ceramed Corp. | 2009-12-09 |
| PEPGEN 15 (P990033/S015) | Ceramed Corp. | 2008-01-11 |
| PEPGEN P-15, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY (P990033/S014) | Ceramed Corp. | 2007-08-09 |
| PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL WITH BIOLOGIC COMPONENT (P990033/S008) | Ceramed Corp. | 2006-10-05 |
| PEPGEN P-15 DENTAL BONE GRAFTING MATERIAL AND BIOLOGIC COMPONENT (P990033/S007) | Ceramed Corp. | 2006-06-06 |
| PEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY (P990033/S005) | Ceramed Corp. | 2004-03-15 |
| PEPGEN P-15 AND PEPGEN P-15 FLOW (P990033/S004) | Ceramed Corp. | 2002-06-14 |