HemiCAP® 9122-2030-W
GUDID M52891222030W0
12mm Art Comp 2.0mm x 3.0mm, MTP CE
ARTHROSURFACE INCORPORATED
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 | M52891222030W0 |
| NIH Device Record Key | ec179e7f-e629-4da1-b88b-03d403853cab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HemiCAP® |
| Version Model Number | 9122-2030-W |
| Catalog Number | 9122-2030-W |
| Company DUNS | 144666109 |
| Company Name | ARTHROSURFACE INCORPORATED |
| 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 | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com | |
| Phone | 508-520-3003 |
| contact@arthrosurface.com |
Device Dimensions
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
| Outer Diameter | 12 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M52891222030W0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063370
FDA Product Code
| KWD | Prosthesis, Toe, Hemi-, Phalangeal |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-02-21 |
| Device Publish Date | 2015-09-15 |
On-Brand Devices [HemiCAP®]
| M528800040100 | DISPOSABLE REAMER, 40MM |
| M52891522545W0 | 15mm Articular Comp 2.5mm x 4.5mm MTP CE |
| M52891522545A0 | 15mm Articular Comp 2.5mm x 4.5mm MTP |
| M52891522535W0 | 15mm Articular Comp 2.5mm x 3.5mm MTP CE |
| M52891522535A0 | 15mm Articular Comp 2.5mm x 3.5mm MTP |
| M52891522040W0 | 15mm Articular Comp 2.0mm x 4.0mm MTP CE |
| M52891522040A0 | 15mm Articular Comp 2.0mm x 4.0mm MTP |
| M52891522030W0 | 15mm Articular Comp 2.0mm x 3.0mm MTP CE |
| M52891522030A0 | 15mm Articular Comp 2.0mm x 3.0mm MTP |
| M52891521535W0 | 15mm Articular Comp 1.5mm x 3.5mm MTP CE |
| M52891521535A0 | 15mm Articular Comp 1.5mm x 3.5mm MTP |
| M52891521525W0 | 15mm Articular Comp 1.5mm x 2.5mm MTP CE |
| M52891521525A0 | 15mm Articular Comp 1.5mm x 2.5mm MTP |
| M52891222030W0 | 12mm Art Comp 2.0mm x 3.0mm, MTP CE |
| M52891222030A0 | 12mm Art Comp 2.0mm x 3.0mm, MTP |
| M52891222025W0 | 12mm Art Comp 2.0mm x 2.5mm, MTP CE |
| M52891222025A0 | 12mm Art Comp 2.0mm x 2.5mm, MTP |
| M52891221525W0 | 12mm Art Comp 1.5mm x 2.5mm, MTP CE |
| M52891221525A0 | 12mm Art Comp 1.5mm x 2.5mm, MTP |
| M52891221520W0 | 12mm Art Comp 1.5mm x 2.0mm, MTP CE |
| M52891221520A0 | 12mm Art Comp 1.5mm x 2.0mm, MTP |
| M52891221020W0 | 12mm Art Comp 1.0mm x 2.0mm, MTP CE |
| M52891221020A0 | 12mm Art Comp 1.0mm x 2.0mm, MTP |
| M52891221015W0 | 12mm Art Comp 1.0mm x 1.5mm, MTP CE |
| M52891221015A0 | 12mm Art Comp 1.0mm x 1.5mm, MTP |
| M52890950018W0 | 9.5mm x 18mm, Taper Post, MTP CE |
| M52890950018A0 | 9.5mm x 18mm, Taper Post, MTP |
| M52890800016W0 | 8.0mm x 16mm, Taper Post, MTP CE |
| M52890800016A0 | 8.0mm x 16mm, Taper Post, MTP |
| M52890700013W0 | Taper Post, 7.0mm Dia X 13mm Lg, MTP CE |
Trademark Results [HemiCAP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMICAP 78225563 3039890 Live/Registered |
ARTHROSURFACE INCORPORATED 2003-03-14 |
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