FDA UDI
In Commercial Distribution
🇺🇸 United States
HyperFlex® Bunion Correction System
DI: G559HF2910RT0
·
Model: HF-2910-RT
·
HYPERFLEX MEDICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HyperFlex® Bunion Correction System
- Primary DI
- G559HF2910RT0
- Version / Model
- HF-2910-RT
- Company Name
- HYPERFLEX MEDICAL INC.
- Labeler DUNS
- 119512231
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-01
- Public Version
- 1
- Public Version Date
- 2026-01-09
- Public Version Status
- New
- Public Device Record Key
- 5ad99183-088e-4c69-bf74-df1311a7faf7
Device Description
Sizer / K-wire Pack - Right
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61246 | Surgical implant/trial-implant/sizer holder, single-use | A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G559HF2910RT0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252997 | 000 |