510(k) K141187
- Device
- IMPIX ALIF S/A
- Applicant
- MEDICREA INTERNATIONAL S.A.
- 510(k) number
- K141187
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-15
- Date received
- 2014-05-08
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID RYAN
- Address
- 14 Porte Du Grand Lyon Neyron FR 01700 01700
FDA Registration Numbers#
- 1834331
- 3005180920
- 3010462278
- 3010863450
- 3017980495
- 3004188066
- 3010009693
- 1526534
- 2032521
- 3016438694
- 1720929
- 3004788213
- 3017048829
- 3018094310
- 3004638600
- 3012447612
- 3006846753
- 3005677016
- 1828464
- 3003120897
- 3005596514
- 3017936978
- 3003935342
- 2530808
- 1835296
- 3003477135
- 2532027
- 3004112448
- 3004717358
- 3011577940
- 3010363503
- 3004893332
- 1057425
- 3009189869
- 3009144915
- 1924669
- 3024999441
- 3004153896
- 3008110533
- 1527105
- 1833920
- 3005031160
- 1835251
- 3009049161
- 3010041430
- 3005497913
- 3017597868
- 3007728266
- 3008992889
- 3016050940
- 1526439
- 3005641619
- 3006639944
- 3015869493
- 1225492
- 3009241418
- 2028632
- 3009417901
- 1649518
- 1424434
- 1424263
- 3010386387
- 3009051471
- 3015398319
- 2032093
- 3006982954
- 3003597504
- 3013820501
- 3004635447
- 9610612
- 3009887475
- 2032098
- 3008864603
- 3015151147
- 3026776
- 3010197224
- 9616680
- 3003898943
- 3005144609
- 3005178931
Source Documents#
Other 510(k) Records For Product Code OVD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261408 | SABER-XA System | Elevation Spine | 2026-08-03 |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | 2026-07-31 |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | 2026-07-15 |
| K260810 | Anteralign LS coverplate | Tyber Medical, LLC | 2026-06-10 |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 |
| K253401 | SCRIPT™ Implant System | Globus Medical, Inc. | 2026-04-29 |
| K253559 | Ventana™ A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | Alphatec Spine | 2025-09-03 |
| K250072 | CONDUIT™ SYNFIX™ Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 |
| K251459 | OneLIF™ Interbody Fusion System | Novapproach Spine, LLC | 2025-06-12 |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 |
Legacy Summary#
summary
FDA Review#
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