PERLA® TL posterior osteosynthesis system
FDA 510(k) clearance K193396 · decided 2020-02-05
Clearance details
- K-number
- K193396
- Device name
- PERLA® TL posterior osteosynthesis system
- Applicant
- Spineart
- Decision
- Substantially Equivalent
- Date received
- 2019-12-06
- Decision date
- 2020-02-05
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Plan Les Ouates, CH
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Spineart
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS recall (Z-1758-2024) | SPINEART SA | 2024-05-03 |