510(k) K202777
- Device
- VeriFixx? Small Bone Implant
- Applicant
- Armis Biopharma, Inc.
- 510(k) number
- K202777
- Product code
- HTY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-11-17
- Date received
- 2020-09-22
- Regulation
- 888.3040
- Classification name
- Pin, Fixation, Smooth
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Franklin Okumu
- Address
- 2950 E. Harmony Rd. Suite 252 Fort Collins CO US 80528 80528
FDA Registration Numbers#
- 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
- 3006395932
- 2031093
- 2032098
- 3009110133
- 3005827567
- 3007125392
- 3025141
- 3021393544
- 3016438694
- 3015539532
- 1825034
- 3015974593
- 3006742481
- 3040335671
- 3006783837
- 2184171
- 3030655570
- 1000517406
- 9681465
- 3013540005
- 3007109793
- 1226191
- 1828464
- 3008749819
- 3009631939
- 3000270450
- 3015207155
- 3008812251
- 3004638532
- 1424263
- 3035366890
- 2183946
- 3005562917
- 3014302784
- 1643264
- 3010673850
- 1043534
- 3008021110
- 2530154
- 3006638824
Source Documents#
Other 510(k) Records For Product Code HTY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262722 | Primal K-Wire (P99-193-1410) | Paragon 28, Inc. | 2026-08-28 |
| K253325 | ZipToe™ Hammertoe Fusion System | Toetal Solutions | 2025-12-29 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 |
| K250315 | RONAVIS – FX (FX-001) | AIRS, Inc. | 2025-08-01 |
| K251362 | PediFlex™ Flexible Nail System | OrthoPediatrics Corp. | 2025-06-24 |
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 |
| K241014 | Biomet Kirschner Wires (K-Wires) | Biomet, Inc. | 2024-05-22 |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail | OSSIO , Ltd. | 2023-12-01 |
| K231147 | Hammerdesis™ Interphalangeal Fusion System | Intelivation | 2023-09-14 |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation Nail | OSSIO , Ltd. | 2023-09-13 |
| K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023-08-14 |
| K231339 | Tyber Medical Pin and Wire System (various) | Tyber Medical, LLC | 2023-07-06 |
| K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022-09-06 |
| K220906 | SECURE-LOCK | Xiros, Ltd. | 2022-07-22 |
| K213982 | Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires | Pacific Instruments | 2022-02-17 |