Megalodon Dynamic Compression System
Paragon 28, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Centennial
- Advisory committee description
- Orthopedic
- Address 1
- 14445 Grasslands Dr.
- Statement or summary
- Summary
- Product code
- JDR
- Zip code
- 80112
- Applicant
- Paragon 28, Inc.
- Decision date
- 2026-08-06
- Decision code
- SESE
- Country code
- US
- Device name
- Megalodon Dynamic Compression System
- Advisory committee
- OR
- Contact
- Brittanie Dogue
- K number
- K261121
- State
- CO
- Date received
- 2026-04-03
- Review advisory committee
- OR
- Postal code
- 80112
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Staple, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3030
- Device class
- 2
- Registration number
- 3011301313, 1221934, 3013176080, 1417592, 3008951116, 3015718210, 3017210488, 1526711, 3006460162, 3026586698, 2029275, 3010041511, 3010462278, 3019269298, 3011874600, 1835831, 1647149, 3010123256, 1030489, 1226183, 3016851379, 3004365956, 1833920, 3008110533, 1038671, 3032588003, 1048735, 3026576110, 3003604053, 1319660, 1450662, 2936485, 3023808054, 3012470322, 3034676720, 3017980495, 3015183635, 3010470577, 1833986, 2032098 +206 more
- FEI number
- 3011301313, 1221934, 3013176080, 1417592, 3008951116, 3015718210, 3017210488, 1526711, 3006460162, 3026586698, 3003056094, 1000116116, 3010041511, 3010462278, 3019269298, 3008647423, 3002757549, 3011874600, 3010123256, 3016851379, 3004365956, 3002807113, 1000120613, 3008110533, 1038671, 3001644153, 3032588003, 1048735, 3026576110, 3003604053, 1450662, 2936485, 3023808054, 3012470322, 3034676720, 3017980495, 3015183635, 3010470577, 3009110133, 3005827567 +206 more