510(k) K173432
- Device
- ENZA-A Titanium ALIF
- Applicant
- Camber Spine Technologies
- 510(k) number
- K173432
- Product code
- OVD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-04-18
- Date received
- 2017-11-02
- 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
- Damian Heinz
- Address
- 418 E. Lancaster Ave. Wayne PA US 19087 19087
FDA Registration Numbers#
- 3003935342
- 3017980495
- 3007766698
- 3010386387
- 3043543260
- 3013194153
- 3012131184
- 3010370554
- 3019878714
- 3010120135
- 3006272282
- 3006404071
- 3015399803
- 3009962553
- 3010160527
- 3005739886
- 3005061536
- 1649379
- 3022295665
- 3009882675
- 3002807561
- 1423662
- 3010097171
- 1835251
- 3000170817
- 1000432246
- 1928237
- 3023852420
- 1833920
- 9615766
- 3016237080
- 1424263
- 3007303113
- 3004024955
- 3015398319
- 3005180920
- 8020776
- 3005031160
- 2032093
- 3007922509
- 3006017180
- 3011127597
- 2134285
- 3010049501
- 3004153896
- 3039167712
- 1835296
- 1057425
- 3030412764
- 3003597504
- 3000270450
- 2032521
- 3010120148
- 3007993775
- 3011577940
- 3015941638
- 3018094310
- 3009887475
- 3012428435
- 3004774118
- 3009144915
- 3015869492
- 1526439
- 3003761012
- 3011390763
- 3005819474
- 3003898943
- 3010009693
- 2532027
- 3004893332
- 3009973336
- 3013820501
- 3015151147
- 3010123206
- 3010370500
- 3005596514
- 9681465
- 2135156
- 1833824
- 3010197239
Source Documents#
Other 510(k) Records For Product Code OVD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | 2026-09-11 |
| 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 |
Legacy Summary#
summary
FDA Review#
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