Xpine Spinal Fixation System
510(k) K243004
Xpine Spinal Fixation System is a Class II device made by Jeil Medical Corporation, cleared under FDA 510(k) K243004 on 8 Nov 2024, 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 | NumberK243004 | Date8 Nov 2024 | StatusActive |
Official records
- FDA 510(k) database K243004
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K243004
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 | |||
|---|---|---|---|---|
| Xpine Spinal Fixation System L69-CLA-3442 | L69-CLA-3442 | 08800089444649 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-4030 | L69-M60A-4030 | 08800089437030 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-4060 | L69-M60A-4060 | 08800089437092 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-4545 | L69-M60A-4545 | 08800089437153 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-6045 | L69-M60A-6045 | 08800089437429 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-6585 | L69-M60A-6585 | 08800089437603 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-7545 | L69-M60A-7545 | 08800089437863 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-7575 | L69-M60A-7575 | 08800089437924 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-7585 | L69-M60A-7585 | 08800089437948 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-8060 | L69-M60A-8060 | 08800089438068 | — | On the market |
| Xpine Spinal Fixation System L69-M60A-8530 | L69-M60A-8530 | 08800089438174 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-5025 | L69-P60A-5025 | 08800089438501 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-5540 | L69-P60A-5540 | 08800089438624 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-6050 | L69-P60A-6050 | 08800089438730 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-7060 | L69-P60A-7060 | 08800089439027 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-7525 | L69-P60A-7525 | 08800089439126 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-8050 | L69-P60A-8050 | 08800089439348 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-8540 | L69-P60A-8540 | 08800089439492 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-8585 | L69-P60A-8585 | 08800089439584 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-9565 | L69-P60A-9565 | 08800089439881 | — | On the market |
| Xpine Spinal Fixation System L69-P60A-9590 | L69-P60A-9590 | 08800089439935 | — | On the market |
| Xpine Spinal Fixation System L69-RM60A-4035 | L69-RM60A-4035 | 08800089439997 | — | On the market |
| Xpine Spinal Fixation System L69-RM60A-6560 | L69-RM60A-6560 | 08800089440504 | — | On the market |
| Xpine Spinal Fixation System L69-RM60A-7585 | L69-RM60A-7585 | 08800089440894 | — | On the market |
| Xpine Spinal Fixation System L69-RM60A-8040 | L69-RM60A-8040 | 08800089440979 | — | On the market |
| Xpine Spinal Fixation System L69-RM60A-8045 | L69-RM60A-8045 | 08800089440986 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-4055 | L69-RP60A-4055 | 08800089441334 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-4525 | L69-RP60A-4525 | 08800089441365 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-5030 | L69-RP60A-5030 | 08800089441464 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-5040 | L69-RP60A-5040 | 08800089441488 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-5045 | L69-RP60A-5045 | 08800089441495 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-5535 | L69-RP60A-5535 | 08800089441563 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-7020 | L69-RP60A-7020 | 08800089441891 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-7045 | L69-RP60A-7045 | 08800089441945 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-8050 | L69-RP60A-8050 | 08800089442294 | — | On the market |
| Xpine Spinal Fixation System L69-RP60A-8525 | L69-RP60A-8525 | 08800089442416 | — | On the market |
| Xpine Spinal Fixation System L69-TCR-5575 | L69-TCR-5575 | 08800089443109 | — | On the market |
| Xpine Spinal Fixation System L69-TCR-60115 | L69-TCR-60115 | 08800089443185 | — | On the market |
| Xpine Spinal Fixation System L69-TCR-60145 | L69-TCR-60145 | 08800089443246 | — | On the market |
| Xpine Spinal Fixation System L69-TCR-6075 | L69-TCR-6075 | 08800089443352 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-55120 | L69-TSR-55120 | 08800089443444 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-55170 | L69-TSR-55170 | 08800089443543 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-55175 | L69-TSR-55175 | 08800089443550 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-55260 | L69-TSR-55260 | 08800089443666 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-55330 | L69-TSR-55330 | 08800089443741 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-5545 | L69-TSR-5545 | 08800089443840 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-5560 | L69-TSR-5560 | 08800089443871 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-60130 | L69-TSR-60130 | 08800089444014 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-60260 | L69-TSR-60260 | 08800089444212 | — | On the market |
| Xpine Spinal Fixation System L69-TSR-60280 | L69-TSR-60280 | 08800089444236 | — | On the market |
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