THREADED CEMENT RESTRICTOR (CR) TITANIUM
FDA 510(k) clearance K011443 · decided 2001-08-03
Clearance details
- K-number
- K011443
- Device name
- THREADED CEMENT RESTRICTOR (CR) TITANIUM
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Decision
- Unknown
- Date received
- 2001-05-11
- Decision date
- 2001-08-03
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JDK
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Memphis, TN, 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.
| Record | Firm | Date |
|---|---|---|
| Mectaplug PE II (K210062) | Medacta International S.A. | 2021-04-08 |
| KMI CEMENT RESTRICTOR IMPLANT (K061465) | Kinetikos Medical, Inc. | 2006-10-05 |
| MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR (K061698) | Life Spine | 2006-07-12 |
| LIFE SPINE CEMENT RESTRICTOR (K060247) | Life Spine | 2006-05-11 |
| SPINAL USA CEMENT RESTRICTOR SYSTEM (K060132) | Spinal USA | 2006-03-16 |
| INTERBODY INNOVATIONS CEMENT RESTRICTOR (K051371) | Interbody Innovations, Llp | 2005-12-06 |
| SKELITE RESORBABLE CEMENT RESTRICTOR (K051836) | Millenium Biologix, Inc. | 2005-11-21 |
| NOVASPINE CEMENT RESTRICTOR NSCR (K051607) | Novaspine, LLC | 2005-10-07 |
| SCIENT'X CEMENT RESTRICTOR (K052367) | Scient'X | 2005-10-05 |
| POLYGRAFT BGS; BONE GRAFT SUBSTITUTE (K041382) | Osteobiologics, Inc. | 2005-06-17 |
| MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 (K050699) | Amedica Corp. | 2005-04-15 |
| PEEK CEMENT RESTRICTOR X-BOX (K041583) | Innovasis, Inc. | 2004-07-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (P000058/S094) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE® Bone Graft (P000054/S074) | Medtronic Sofamor Danek USA, Inc. | 2025-03-19 |
| INFUSE Bone Graft/Medtronic Interbody Fusion Device (P000058/S093) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| INFUSE Bone Graft (P000054/S073) | Medtronic Sofamor Danek USA, Inc. | 2024-11-06 |
| Prestige LP (R) Cervical Disc (P090029/S021) | Medtronic Sofamor Danek USA, Inc. | 2024-08-09 |
| Prestige LP (R) Cervical Disc (P090029/S020) | Medtronic Sofamor Danek USA, Inc. | 2024-05-01 |
| Prestige LP Cervical Disc (P090029/S018) | Medtronic Sofamor Danek USA, Inc. | 2024-02-21 |
| Prestige LP® Cervical Disc (P090029/S019) | Medtronic Sofamor Danek USA, Inc. | 2023-10-26 |