PROGENIX PLUS
FDA 510(k) clearance K081950 · decided 2008-07-18
Clearance details
- K-number
- K081950
- Device name
- PROGENIX PLUS
- Applicant
- Medtronic Sofamor Danek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-09
- Decision date
- 2008-07-18
- Days to decision
- 9 days
- Clearance type
- Special
- Product code
- NUN
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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| DBX DEMINERALIZED BONE MATRIX PUTTY (K091217) | Musculoskeletal Transplant Foundation | 2009-10-02 |
| PROGENIX (K082463) | Medtronic Sofamor Danek | 2008-11-10 |
| PROGENIX DBM PUTTY (K080462) | Medtronic Sofamor Danek | 2008-05-13 |
| REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST (K080418) | Regeneration Technologies, Inc. | 2008-04-30 |
| INTERGRO ORAL (K070147) | Biomet 3i | 2007-05-14 |
| ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (K060332) | Isotis NV | 2006-03-29 |
| ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (K060306) | Isotis NV | 2006-03-27 |
| GRAFTON DBM (K051188) | Osteotech, Inc. | 2006-01-03 |
| GRAFTON PLUS DBM PASTE (K042707) | Osteotech, Inc. | 2005-11-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PRESTIGE CERVICAL DISC SYSTEM (P060018/S005) | Medtronic Sofamor Danek, Inc. | 2016-08-11 |
| PRESTIGE® Cervical Disc (P060018/S004) | Medtronic Sofamor Danek, Inc. | 2016-07-20 |
| X-STOP LTOS (P040001/S021) | Medtronic Sofamor Danek, Inc. | 2014-12-12 |
| X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM (P040001/S022) | Medtronic Sofamor Danek, Inc. | 2014-10-24 |
| PRESTIGE CERVICAL DISC (P060018/S003) | Medtronic Sofamor Danek, Inc. | 2013-07-12 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S020) | Medtronic Sofamor Danek, Inc. | 2012-07-25 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S019) | Medtronic Sofamor Danek, Inc. | 2011-05-04 |
| PRESTIGE CERVICAL DISC (P060018/S002) | Medtronic Sofamor Danek, Inc. | 2011-03-24 |