Data / Medical devices / United States / BK Meditech, Usa
BK Meditech, Usa: FDA-registered device maker in San Antonio, TX, United States, 5 510(k) clearances
BK Meditech, Usa is registered with the FDA (registration 3016244279) in San Antonio, TX, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 11, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016244279
- Address
- 219 Tampico Street, San Antonio, TX, United States, 78207
- Owner or operator
- BK Meditech, USA (10062179)
- Roles
- Repackager or relabeler
- First device listed
- May 3, 2024
- Registered through
- 2026
- Brand names listed
- INNESIS PEEK CAGE, INNESIS PEEK CERVICAL CAGE, INNESIS PEEK TL CAGE, Mega Plus MIS Spine System, Mega Plus Spine System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Thoracolumbosacral Pedicle Screw System | NKB | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 11, 2020 | K200981 | Mega Plus MIS Spine System | NKB | Substantially Equivalent | Bk Meditech, Co., Ltd. | accessdata.fda.gov |
| March 15, 2018 | K173180 | Mega Plus Spine System | NKB | Substantially Equivalent | Bk Meditech, Co., Ltd. | accessdata.fda.gov |
| October 1, 2014 | K140577 | INNESIS PEEK TL CAGE | MAX | Substantially Equivalent | Bk Meditech, Co., Ltd. | accessdata.fda.gov |
| April 2, 2014 | K132483 | INNESIS PEEK CERVICAL CAGE | ODP | Substantially Equivalent | Bk Meditech, Co., Ltd. | accessdata.fda.gov |
| January 18, 2013 | K120464 | INNESIS PEEK CAGE | MAX | Substantially Equivalent | Bk Meditech, Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Thoracolumbosacral Pedicle Screw System
- All makers of Intervertebral Fusion Device With Bone Graft, Cervical
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
Updated August 11, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.