BioPoly® Great Toe Hemiarthroplasty Implant 135-5122
GUDID 00850005618195
BioPoly® Great Toe Hemiarthroplasty Implant - 22mm Porous
Biopoly, LLC
Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis| Primary Device ID | 00850005618195 |
| NIH Device Record Key | 870fb9b5-4659-4201-a358-21f062d9526c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioPoly® Great Toe Hemiarthroplasty Implant |
| Version Model Number | 135-5122 |
| Catalog Number | 135-5122 |
| 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
Device Dimensions
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
| Outer Diameter | 22 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005618195 [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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