EnHAnce PEEK Bunion System
Nvision Biomedical Technologies · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- San Antonio
- Advisory committee description
- Orthopedic
- Address 1
- 12449 Silicon Dr.
- Statement or summary
- Summary
- Product code
- HRS
- Zip code
- 78249
- Applicant
- Nvision Biomedical Technologies
- Decision date
- 2026-09-18
- Decision code
- SESE
- Country code
- US
- Device name
- EnHAnce PEEK Bunion System
- Advisory committee
- OR
- Contact
- Marisa Zink
- K number
- K262098
- State
- TX
- Date received
- 2026-06-22
- Review advisory committee
- OR
- Postal code
- 78249
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Plate, Fixation, Bone
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3030
- Device class
- 2
- Registration number
- 2249615, 3013176080, 3008951116, 9610921, 3006849754, 3013843055, 2029275, 9611274, 3010057495, 3012447612, 1835831, 3004635447, 3010123256, 3008285983, 1528646, 3009532798, 3023808054, 3031261833, 2032098, 3009998573, 3043026734, 1221051, 1424434, 3004049923, 3013540005, 3043543260, 3034525, 3009153862, 3004549189, 2024024, 3010673850, 3009540749, 3011656326, 9710629, 3012818475, 3015542154, 3009417901, 3016247852, 3005983700, 3022159082 +483 more
- FEI number
- 3013176080, 3008951116, 3003056094, 3006849754, 3013843055, 1000116116, 3010057495, 3012447612, 3004635447, 3010123256, 3008285983, 3002459190, 3002807113, 3009532798, 3023808054, 3031261833, 1000136451, 3009998573, 3043026734, 1221051, 3003110073, 3004049923, 1000115656, 3013540005, 3002786339, 3043543260, 3009153862, 3000215273, 2024024, 3010673850, 3009540749, 3011656326, 3012818475, 3015542154, 3009417901, 5870, 3016247852, 3005983700, 3022159082, 3010440433 +483 more