FDA UDI
In Commercial Distribution
🇺🇸 United States
BioPoly® Lesser Toe Hemiarthroplasty Implant
DI: 00850005618133
·
Model: 130-5112
·
Biopoly, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BioPoly® Lesser Toe Hemiarthroplasty Implant
- Primary DI
- 00850005618133
- Version / Model
- 130-5112
- Catalog Number
- 130-5112
- Company Name
- Biopoly, LLC
- Labeler DUNS
- 023778928
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-25
- Public Version
- 1
- Public Version Date
- 2023-11-02
- Public Version Status
- New
- Public Device Record Key
- 63481bed-54d6-4104-bad1-7f1bac24c58e
Device Description
BioPoly® Lesser Toe Hemiarthroplasty Implant - 12mm Porous
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 |
|---|---|---|---|---|
| KWD | Prosthesis, Toe, Hemi-, Phalangeal | Orthopedic | 888.3730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33696 | Partial metatarsophalangeal joint prosthesis | An implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850005618133 | GS1 |
Customer Contacts
- Phone
- 260-999-6135
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222964 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12 | Millimeter |