Luque Segmental Spinal Instrumentation
by Zimmer, Inc.
510(k) K913561
Luque Segmental Spinal Instrumentation is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K913561 on 16 Jan 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK913561 | Date16 Jan 1992 | StatusActive |
Official records
- FDA 510(k) database K913561
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K913561
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 1292-60 | 00-1292-060-00 / 1292-60 | 00889024038035 | Length 20 cm | On the market |
| 1292-61 | 00-1292-061-00 / 1292-61 | 00889024038042 | Length 30 cm | On the market |
| 1292-62 | 00-1292-062-00 / 1292-62 | 00889024038059 | Length 20 cm | On the market |
| 1292-63 | 00-1292-063-00 / 1292-63 | 00889024038066 | Length 30 cm | On the market |
| 1292-70 | 00-1292-070-00 / 1292-70 | 00889024038073 | Length 20 cm | On the market |
| 1292-71 | 00-1292-071-00 / 1292-71 | 00889024038080 | Length 30 cm | On the market |
| 1292-72 | 00-1292-072-00 / 1292-72 | 00889024038097 | Length 20 cm | On the market |
| 1292-73 | 00-1292-073-00 / 1292-73 | 00889024038103 | Length 30 cm | On the market |
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