EXPERT - Flexible Joint Fixation System
FDA 510(k) clearance K242311 · decided 2024-11-01
Clearance details
- K-number
- K242311
- Device name
- EXPERT - Flexible Joint Fixation System
- Applicant
- GM Dos Reis Industria e Comercio Ltda.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-05
- Decision date
- 2024-11-01
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- HTN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Campinas, BR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch GM Dos Reis Industria e Comercio Ltda.
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.
| Record | Firm | Date |
|---|---|---|
| LARS ACJ (K253115) | Movmedix S.A.S. | 2026-06-10 |
| SportLinc Syndesmosis Device (K252081) | Lincotek Medical | 2026-03-27 |
| Syndesmosis TightRope PRO (K253727) | Arthrex, Inc. | 2025-12-22 |
| Synchfix EVT (K251643) | Wright Medical Technology, Inc. (Stryker Corporation) | 2025-10-29 |
| RipCord (K251134) | TriMed, Inc. | 2025-07-11 |
| Acu-Sinch Knotless Mini (K243624) | Acumed, LLC | 2025-01-23 |
| Bolo Button System (K242091) | Fusion Orthopedics | 2024-12-23 |
| TACTIX Vector Syndesmosis System (K243408) | Vilex, LLC | 2024-11-27 |
| TACTIX Vector Syndesmosis System (K240035) | Vilex, LLC | 2024-08-01 |
| TENSOR® Suture Button System (K240947) | Globus Medical, Inc. | 2024-06-03 |
| OIC FLEX-FIX™ System (K233531) | Orthopaedic Implant Company | 2024-02-02 |
| CC-Clip® Implant System (K232780) | Cc-Instruments, Inc. | 2023-12-18 |
Recalls involving this device
No recalls on record reference this clearance.