Primal K-Wire (P99-193-1410)
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
- HTY
- Zip code
- 80112
- Applicant
- Paragon 28, Inc.
- Decision date
- 2026-08-28
- Decision code
- SESE
- Country code
- US
- Device name
- Primal K-Wire (P99-193-1410)
- Advisory committee
- OR
- Contact
- Daniel Nelson
- K number
- K262722
- State
- CO
- Date received
- 2026-07-31
- Review advisory committee
- OR
- Postal code
- 80112
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Pin, Fixation, Smooth
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3040
- Device class
- 2
- Registration number
- 3011301313, 2249615, 1221934, 3013176080, 3026032087, 3008951116, 3011127597, 3042903229, 3006460162, 2431166, 1834331, 3014252644, 2029275, 3010041511, 3010462278, 9611274, 3007539489, 3019269298, 3005061536, 3011874600, 1835831, 3004635447, 3004748528, 3014315669, 1226183, 3016851379, 1833920, 3008110533, 1048735, 3009826895, 3003604053, 1319660, 1450662, 2936485, 3034676720, 3017980495, 2437731, 3010470577, 3010370500, 1833986 +246 more
- FEI number
- 3011301313, 1221934, 3013176080, 3026032087, 3008951116, 3011127597, 3042903229, 3006460162, 3014252644, 1000116116, 3010041511, 3010462278, 3007539489, 3019269298, 3008647423, 3002757549, 3005061536, 3011874600, 3004635447, 3004748528, 3014315669, 3016851379, 3002807113, 3008110533, 1048735, 3009826895, 3003604053, 1450662, 2936485, 3034676720, 3017980495, 3001617730, 3010470577, 3010370500, 3010813691, 3006395932, 3009110133, 3005827567, 3007125392, 3001236277 +246 more