510(k) K111593
- Device
- GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
- Applicant
- BM KOREA CO., LTD.
- 510(k) number
- K111593
- Product code
- NDN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-11-18
- Date received
- 2011-06-07
- 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
- RONALD D ARKIN
- Address
- 1733 Canton Ln. Marietta GA US 30062 30062
FDA Registration Numbers#
- 9617601
- 2029275
- 3008572623
- 3006563559
- 3043534478
- 1423662
- 3021638889
- 3002807314
- 2649614
- 2648623
- 3008110533
- 3013186738
- 3004598644
- 3018094310
- 9615014
- 3005083075
- 3021566676
- 3003678543
- 3008868758
- 3027518990
- 1928237
- 3007955117
- 3014725904
- 3040335671
- 3010509633
- 3009756327
- 1824199
- 8043792
- 3010120148
- 3014003062
- 1526439
- 3004519921
- 3008812560
- 3008583793
- 3017155536
- 1000461041
- 3005180920
- 3009018440
- 3000270450
- 3018242561
- 3009417901
- 9610921
- 9617616
- 3005677016
- 9615788
- 2647346
- 1061927
- 3004734264
- 3013546462
- 3015831087
- 2953359
- 9612420
- 1649518
- 1820334
- 3010162973
- 1526534
- 3016842760
- 3015967359
- 3010173425
- 1123169
- 3008215723
- 2246552
- 3006946276
- 3003916006
- 3006406161
- 3002808022
- 3033589330
- 1030489
- 2530808
- 1424263
- 3010898856
- 2648666
- 3005596514
- 9614841
- 3008132398
- 3008114965
- 3010132111
- 2031093
- 3008125983
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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