BioPoly® Great Toe Hemiarthroplasty Implant 135-5116
GUDID 00850012119395
BioPoly® Great Toe Hemiarthroplasty Implant - 16mm Porous
Biopoly, LLC
Partial metatarsophalangeal joint prosthesis| Primary Device ID | 00850012119395 |
| NIH Device Record Key | aaa4a496-7aa3-4274-a38f-c925fcf35296 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioPoly® Great Toe Hemiarthroplasty Implant |
| Version Model Number | 135-5116 |
| Catalog Number | 135-5116 |
| Company DUNS | 023778928 |
| Company Name | Biopoly, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com | |
| Phone | 260-999-6135 |
| info@biopolyortho.com |
Device Dimensions
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
| Outer Diameter | 16 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850012119395 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203634
FDA Product Code
| KWD | Prosthesis, Toe, Hemi-, Phalangeal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-14 |
| Device Publish Date | 2022-02-04 |
On-Brand Devices [BioPoly® Great Toe Hemiarthroplasty Implant]
| 00850012119418 | BioPoly® Great Toe Hemiarthroplasty Implant - 20mm Porous |
| 00850012119401 | BioPoly® Great Toe Hemiarthroplasty Implant - 18mm Porous |
| 00850012119395 | BioPoly® Great Toe Hemiarthroplasty Implant - 16mm Porous |
| 00850012119388 | BioPoly® Great Toe Hemiarthroplasty Implant - 14mm Porous |
| 00850005618195 | BioPoly® Great Toe Hemiarthroplasty Implant - 22mm Porous |
Trademark Results [BioPoly]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOPOLY 86204584 4620416 Live/Registered |
BIOPOLY, LLC 2014-02-26 |
 BIOPOLY 77932427 3852948 Live/Registered |
BioPoly LLC 2010-02-10 |
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