510(k) K250021
- Device
- Rotium
- Applicant
- Nanofiber Solutions, LLC
- 510(k) number
- K250021
- Product code
- OWW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-27
- Date received
- 2025-01-03
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jason Chakroff
- Address
- 5164 Blazer Pkwy. Dublin OH US 43017 43017
FDA Registration Numbers#
- 3014527904
- 1721676
- 1320894
- 1064858
- 3033302333
- 2030598
- 3000215346
- 3009493875
- 8043792
- 3019101334
- 3010673515
- 3012669262
- 1017294
- 9614442
- 3033273526
Source Documents#
Other 510(k) Records For Product Code OWW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | Alafair Biosciences | 2025-07-18 |
| K242187 | BioBrace® | Conmed Corporation | 2024-11-27 |
| K241906 | BioBrace® Reinforced Implant | Conmed Corporation | 2024-07-29 |
| K240817 | VersaWrap | Alafair Biosciences, Inc. | 2024-06-14 |
| K222220 | SpinMedix Absorbable Fibrous Membrane | Celestray Biotech Company, LLC., | 2023-07-06 |
| K230316 | FlexBand; FlexPatch; FlexBand Plus | International Life Sciences | 2023-05-26 |
| K203267 | The BioBrace Implant | Biorez, Inc. | 2021-04-30 |
| K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016-06-10 |
| K121216 | STR GRAFT | Soft Tissue Regeneration, Inc. | 2012-11-21 |