Submission Details
| 510(k) Number | K200452 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 2020 |
| Decision Date | March 27, 2023 |
| Days to Decision | 1127 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Meril-Bonewax
Mar 2023
Decision
1127d
Days
—
Risk
About This 510(k) Submission
K200452 is an FDA 510(k) clearance for the Meril-Bonewax, a Wax, Bone, submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on March 27, 2023, 1127 days after receiving the submission on February 24, 2020. This device falls under the Orthopedic review panel.
Device Classification
| Product Code | MTJ — Wax, Bone |
| Device Class | — |
Manufacturer
Similar Devices — MTJ Wax, Bone
All 40
K232998 · Orthocon, Inc.
· Oct 2023
K213418 · Orthocon, Inc.
· Aug 2023
K231386 · Orthocon, Inc.
· Jul 2023
K220315 · Orthocon, Inc.
· Mar 2022
K202363 · Orthocon, Inc.
· Jan 2021
K193052 · Orthocon, Inc.
· Mar 2020
More from M/s. Meril Endo Surgery...
View all
K252644
· NEW · Sep 2025
K233386
· GCJ · May 2024
K232246
· NEW · Apr 2024
K230981
· MPN · Mar 2024
K200320
· GDW · Feb 2021