510(k) K251896
- Device
- XeliteMed SuperM-Fix Spinal Bone Cement
- Applicant
- Xelite Biomed , Ltd.
- 510(k) number
- K251896
- Product code
- NDN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-01-28
- Date received
- 2025-06-20
- 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
- N
Related Records
Applicant Contact
- Contact
- Wei Chun Chang
- Address
- 2f., # 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist. New Taipei City TW 231 231
FDA Registration Numbers
- 1423662
- 3005180920
- 3008125983
- 3021566676
- 2530808
- 9616662
- 1000461041
- 3004464325
- 3012536737
- 3027518990
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- 3002808022
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Source Documents
Other 510(k) Records For Product Code NDN
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|---|---|---|---|
| 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 |
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| 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 |
| K191709 | V-STRUT Vertebral Implant | Hyprevention Sas | 2020-03-05 |