510(k) K060148
- Device
- EBI VERTEBROPLASTY SYSTEMS
- Applicant
- EBI, L.P.
- 510(k) number
- K060148
- Product code
- NDN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-13
- Date received
- 2006-01-19
- Regulation
- 888.3027
- Classification name
- Cement, Bone, Vertebroplasty
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARRY E SANDS
- Address
- 399 Jefferson Rd. Parsippany NJ US 07054 07054
FDA Registration Numbers#
- 3005677016
- 3008583793
- 3003678543
- 2649614
- 3015967359
- 3014725904
- 3010132111
- 9610921
- 3008215723
- 3030412764
- 3009018440
- 3008125983
- 3008868758
- 3010162973
- 3005083075
- 3012536737
- 3009509485
- 1724474
- 3004519921
- 3033589330
- 9617616
- 2648666
- 3020163307
- 1030489
- 3014003062
- 3040335671
- 3010898856
- 8043792
- 9615014
- 3004142400
- 2031093
- 9616662
- 1928237
- 3016842760
- 3043534478
- 3015309643
- 3004598644
- 3008132398
- 1526439
- 3004734264
- 1424263
- 3017155536
- 3013546462
- 1820334
- 3010178296
- 1720929
- 9612420
- 3006946276
- 3002806603
- 3006406161
- 3005596514
- 1123169
- 3021638889
- 2648623
- 1649518
- 1061927
- 3006563559
- 3002807314
- 9681465
- 1824199
- 3010071016
- 3002807112
- 3008114965
- 2029275
- 3005827567
- 3018242561
- 3009417901
- 3007955117
- 3005180920
- 2246552
- 2530808
- 3021566676
- 9614841
- 3027518990
- 3015399803
- 1721504
- 3003120897
- 3008328679
- 3006950086
Source Documents#
Other 510(k) Records For Product Code NDN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone Cement | Xelite Biomed , Ltd. | 2026-01-28 |
| K250637 | VCFix Spinal System | Amber Implants | 2025-05-30 |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement System | Xelite Biomed , Ltd. | 2025-04-11 |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement | Xelite Biomed , Ltd. | 2024-09-18 |
| K232842 | Balloon Inflation System | Ningbo Hicren Biotechnology Co., Ltd. | 2024-02-29 |
| K240084 | V-STRUT® Vertebral Implant | Hyprevention | 2024-02-09 |
| K231340 | Renova Spine Balloon Catheter | Biopsybell S.R.L. | 2023-10-30 |
| K221697 | INJECTION PIN (KIP(02031-02061) (03031-03061)) | Slk Ortho, LLC | 2023-03-03 |
| K223294 | SpineJack® Expansion Kit | Stryker Instruments | 2022-12-20 |
| K220131 | KYPHON VuE Bone Cement | Tecres S.P.A. | 2022-04-18 |
| K211797 | TRACKER Plus Kyphoplasty System | GS Medical Co., Ltd. | 2021-10-28 |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | Stryker Instruments | 2021-06-25 |
| K202393 | SpineJack Expansion Kit | Stryker Corporation | 2020-10-20 |
| K201831 | CONFIDENCE Spinal Cement System | Depuy Spine, Inc. | 2020-08-31 |
| K192449 | Joline Kyphoplasty System Allevo | Joline GmbH & Co. KG | 2020-05-27 |
Legacy Summary#
summary
FDA Review#
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