510(k) K221542
- Device
- Galileo Vertebral Body Replacement Device
- Applicant
- Bright Spine
- 510(k) number
- K221542
- Product code
- PLR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-01-13
- Date received
- 2022-05-27
- Regulation
- 888.3060
- Classification name
- Spinal Vertebral Body Replacement Device - Cervical
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Robert Simonson
- Address
- 834 NE 33rd St. Boca Raton FL US 33431 33431
FDA Registration Numbers
- 1450662
- 3008114965
- 1056553
- 3004153896
- 3003477135
- 3014680795
- 3003120897
- 3012131184
- 3013820501
- 3022159082
- 3006639944
- 3033509898
- 3019767615
- 8010099
- 3007922509
- 3010047454
- 3014655115
- 3014252644
- 3009941480
- 3036756245
- 1935627
- 3016438694
- 3006493760
- 3008534770
- 1000493591
- 2027467
- 3010705004
- 3015941638
- 3006128100
- 3019878714
- 3002862271
- 3009973505
- 9612420
- 3006783837
- 3003935342
- 1649518
- 3005706667
- 1030489
- 3025603301
- 9611813
- 3030412764
- 3004188066
- 3004142400
- 3009504230
- 2031966
- 9610612
- 3013491327
- 3009144915
- 3010560653
- 3004024955
- 8043792
- 3010032903
- 3004774118
- 3003761012
- 3010363503
- 3004638532
- 1424263
- 2532027
- 3010120104
- 3007014520
- 1526534
- 3010123206
- 3018094310
- 3005819474
- 3008583793
- 1226544
- 9615128
- 3010049501
Source Documents
Other 510(k) Records For Product Code PLR
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy System | Atlas Spine, Inc. | 2025-11-10 |
| K232481 | RIGEL 3DR Anterior Cervical Corpectomy System | MiRus, LLC | 2023-10-13 |
| K212126 | MediExpand Cervical Expandable VBR System | Cmf Medicon Surgical, Inc. | 2022-04-04 |
| K211320 | CAPRI Corpectomy Cage System | K2m, Inc. | 2022-02-24 |
| K192145 | Galileo Vertebral Body Replacement Device | Bright Spine | 2020-04-21 |
| K193412 | NEXXT MATRIXX System | Nexxt Spine, LLC | 2020-02-24 |
| K190284 | Bengal Stackable Cage System | Medos International SARL | 2019-12-20 |
| K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019-10-24 |
| K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019-08-28 |
| K191423 | Normandy VBR System | Zavation Medical Products, LLC | 2019-08-06 |
| K183071 | VLIFT-s Vertebral Body Replacement System | Stryker Spine | 2019-01-10 |
| K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018-11-20 |
| K173893 | Trabis | Coligne AG | 2018-09-06 |
| K180673 | Normandy VBR System | Zavation Medical Products, LLC | 2018-07-13 |
| K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017-11-20 |