510(k) K133653
- Device
- ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
- Applicant
- MEDTRONIC SOFAMOR DANEK USA, INC.
- 510(k) number
- K133653
- Product code
- ODP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-04-28
- Date received
- 2013-11-27
- Regulation
- 888.3080
- Classification name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JULIE BASSETT
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 3037407500
- 3027201862
- 1724955
- 3010041430
- 3002807112
- 3006846753
- 1057425
- 3021006165
- 3014967552
- 3006110997
- 3013961579
- 3012429289
- 3014725904
- 1030489
- 3015440604
- 1000493591
- 3013820501
- 1835251
- 1834331
- 3004638532
- 2183946
- 9617297
- 3009189869
- 3023189283
- 1000461041
- 3005706667
- 3027726367
- 3009882462
- 3010763958
- 3019356409
- 1645151
- 3013491327
- 1424434
- 3013422238
- 3009217531
- 3003935342
- 1219655
- 3009756327
- 3009169872
- 1833920
- 3005562917
- 3005751028
- 3014937101
- 3033509898
- 3000170817
- 9611390
- 2531477
- 3005977257
- 3025603301
- 3021180147
- 1833986
- 3015991317
- 3011390763
- 3008599979
- 1221051
- 9610612
- 3008868758
- 3010665091
- 1835296
- 3016050940
- 3023434937
- 3010097171
- 1530390
- 3003639920
- 2032521
- 1935627
- 3007993775
- 3012447612
- 8043792
- 2183449
- 1649518
- 2133928
- 3023852420
- 3009504230
- 3030183061
- 3030412764
- 3009941480
- 3009882675
- 3027807601
Source Documents#
Other 510(k) Records For Product Code ODP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion System | Wenzel Spine, Inc. | 2026-08-26 |
| K262489 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-08-18 |
| K253041 | 3d Cage Cervical | Fims Co., Ltd. | 2026-07-23 |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEM | Stryker Spine | 2026-07-17 |
| K254130 | C.A. Medical Interbody Fusion System | C.A. Medical, LLC | 2026-07-08 |
| K260840 | BluEX Cervical Expandable Cage System | L&K BIOMED Co., Ltd. | 2026-05-16 |
| K260850 | OSTEOMNI SPINAL CAGES SYSTEM | Osteomni, Inc. | 2026-05-12 |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System | Zsfab, Inc. | 2026-04-24 |
| K253260 | ORIO-3D Cage System | SpineCraft | 2026-04-16 |
| K260340 | HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES | HC Biologics, LLC | 2026-04-13 |
| K242303 | MOD-C | Orthomod, LLC | 2026-04-01 |
| K252240 | Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System | Spectrum Spine | 2026-03-30 |
| K252432 | Flex-Z™ Cervical Cage | Spinepoint, LLC | 2026-03-25 |
| K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | NanoHive Medical, LLC | 2026-02-13 |
| K252205 | Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2026-01-16 |
Legacy Summary#
summary
FDA Review#
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