ENDURAMESH, MODEL 762.XXX
FDA 510(k) clearance K093207 · decided 2010-04-26
Clearance details
- K-number
- K093207
- Device name
- ENDURAMESH, MODEL 762.XXX
- Applicant
- Lucero Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-10-13
- Decision date
- 2010-04-26
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- MQP
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Richfield, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Lucero Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Vertiwedge® Intraosseous System (K261810) | Foundation Surgical Group | 2026-07-31 |
| POSEIDON ST (K261031) | Signus Medinzintechnik GmbH | 2026-07-10 |
| VyBrate™ VBR System (K253158) | Vy Spine, LLC | 2026-01-07 |
| Vertiwedge® Intraosseous System (K241468) | Foundation Surgical Group, Inc. | 2024-11-07 |
| KONG®-TL VBR System and KONG® C VBR System (K232790) | Icotec AG | 2024-04-04 |
| DOMINION Expandable Corpectomy System (K233359) | Astura Medical | 2024-03-08 |
| VerteLoc Spinal System (K231134) | Signature Orthopaedics Pty, Ltd. | 2024-02-13 |
| Ascend VBR System, Ascend NanoTec VBR System (K232173) | Alphatec Spine, Inc. | 2023-10-06 |
| ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (K211892) | Arftx Medical, LLC | 2022-10-06 |
| F3D Corpectomy System (K202637) | Corelink, LLC | 2020-12-23 |
| KONG-TL VBR System, KONG-C VBR System (K200235) | Icotec AG | 2020-05-29 |
| NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System (K193506) | Nu Vasive, Incorporated | 2020-02-26 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body repl recall (Z-2368-2012) | Lucero Medical LLC | 2012-09-11 |