FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
PERLA® TL System; TEKTONA® HV US Bone Cement
K Number: K230774
·
Decision Jun 23, 2023
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
18
Applicant Total
44
Review Days
94
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Basic Information
- Device Name
- PERLA® TL System; TEKTONA® HV US Bone Cement
- K Number
- K230774
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3027
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spineart
- Date Received
- March 21, 2023
- Decision Date
- June 23, 2023
- Product Code
- PML
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PML | Bone Cement, Posterior Screw Augmentation | FDA class 2 | Orthopedic |
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Other Clearances by Spineart
| K Number | Device Name | ||
|---|---|---|---|
| K213470 | PERLA® TL Posterior Osteosynthesis System | Jan 21, 2022 | Substantially Equivalent |
| K210472 | SPINEART Navigation Instrument System | Mar 19, 2021 | Substantially Equivalent |
| K203506 | PERLA® TL posterior osteosynthesis system | Jan 15, 2021 | Substantially Equivalent |
| K203222 | PERLA TL Posterior Osteosynthesis System | Dec 17, 2020 | Substantially Equivalent |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | May 1, 2020 | Substantially Equivalent |
| K200312 | Tryptik Ti | Apr 6, 2020 | Substantially Equivalent |
| K193396 | PERLA® TL posterior osteosynthesis system | Feb 5, 2020 | Substantially Equivalent |
| K192993 | SCARLET AL-T | Jan 22, 2020 | Substantially Equivalent |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | May 29, 2019 | Substantially Equivalent |
| K190322 | SCARLET® AC-T Secured Anterior Cervical Cage | Mar 4, 2019 | Substantially Equivalent |