Arrow Reverse Shoulder System
by Fournitures Hospitalieres Industrie
510(k) K112193
Arrow Reverse Shoulder System is a Class II device made by Fournitures Hospitalieres Industrie, cleared under FDA 510(k) K112193 on 12 Jul 2012, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112193 | Date12 Jul 2012 | StatusActive |
Official records
- FDA 510(k) database K112193
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PHX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3660
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K112193
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ARROW® | 265153 - CEMENTLESS METAL-BACK GLENOID BASE, S44 | 03661489651533 | — | On the market |
| ARROW® | 265154 - CEMENTLESS METAL-BACK GLENOID BASE, S46 | 03661489651540 | — | On the market |
| ARROW® | 265155 - CEMENTLESS METAL-BACK GLENOID BASE, S48 | 03661489651557 | — | On the market |
| ARROW® 265141 - STD HUMERAL INSERT, Ø36 / H00 | 265141 - STD HUMERAL INSERT, Ø36 / H00 | 03661489651410 | — | On the market |
| ARROW® 265142 - STD HUMERAL INSERT, Ø36 / H05 | 265142 - STD HUMERAL INSERT, Ø36 / H05 | 03661489651427 | — | On the market |
| ARROW® 265143 - STD HUMERAL INSERT, Ø36 / H10 | 265143 - STD HUMERAL INSERT, Ø36 / H10 | 03661489651434 | — | On the market |
| ARROW® 265144 - STD HUMERAL INSERT, Ø39 / H00 | 265144 - STD HUMERAL INSERT, Ø39 / H00 | 03661489651441 | — | On the market |
| ARROW® 265145 - STD HUMERAL INSERT, Ø39 / H05 | 265145 - STD HUMERAL INSERT, Ø39 / H05 | 03661489651458 | — | On the market |
| ARROW® 265146 - STD HUMERAL INSERT, Ø39 / H10 | 265146 - STD HUMERAL INSERT, Ø39 / H10 | 03661489651465 | — | On the market |
| ARROW® 265147 - STD HUMERAL INSERT, Ø42 / H00 | 265147 - STD HUMERAL INSERT, Ø42 / H00 | 03661489651472 | — | On the market |
| ARROW® 265148 - STD HUMERAL INSERT, Ø42 / H05 | 265148 - STD HUMERAL INSERT, Ø42 / H05 | 03661489651489 | — | On the market |
| ARROW® 265149 - STD HUMERAL INSERT, Ø42 / H10 | 265149 - STD HUMERAL INSERT, Ø42 / H10 | 03661489651496 | — | On the market |
| ARROW® 265150 - CoCr GLENOSPHERE, Ø36 | 265150 - CoCr GLENOSPHERE, Ø36 | 03661489651502 | — | On the market |
| ARROW® 265151 - CoCr GLENOSPHERE, Ø39 | 265151 - CoCr GLENOSPHERE, Ø39 | 03661489651519 | — | On the market |
| ARROW® 265152 - CoCr GLENOSPHERE, Ø42 | 265152 - CoCr GLENOSPHERE, Ø42 | 03661489651526 | — | On the market |
| ARROW® 265161 - CANCELLOUS BONE SCREW, Ø5,5 L32 | 265161 - CANCELLOUS BONE SCREW, Ø5,5 L32 | 03661489651618 | — | On the market |
| ARROW® 265162 - CANCELLOUS BONE SCREW, Ø5,5 L34 | 265162 - CANCELLOUS BONE SCREW, Ø5,5 L34 | 03661489651625 | — | On the market |
| ARROW® 265163 - CANCELLOUS BONE SCREW, Ø5,5 L36 | 265163 - CANCELLOUS BONE SCREW, Ø5,5 L36 | 03661489651632 | — | On the market |
| ARROW® 265164 - CANCELLOUS BONE SCREW, Ø5,5 L38 | 265164 - CANCELLOUS BONE SCREW, Ø5,5 L38 | 03661489651649 | — | On the market |
| ARROW® 265165 - CANCELLOUS BONE SCREW, Ø5,5 L40 | 265165 - CANCELLOUS BONE SCREW, Ø5,5 L40 | 03661489651656 | — | On the market |
| ARROW® 265166 - CANCELLOUS BONE SCREW, Ø5,5 L45 | 265166 - CANCELLOUS BONE SCREW, Ø5,5 L45 | 03661489651663 | — | On the market |
| ARROW® 265167 - CANCELLOUS BONE SCREW, Ø5,5 L50 | 265167 - CANCELLOUS BONE SCREW, Ø5,5 L50 | 03661489651670 | — | On the market |
| ARROW® 265168 - CORTICAL BONE SCREW, Ø4,5 L32 | 265168 - CORTICAL BONE SCREW, Ø4,5 L32 | 03661489651687 | — | On the market |
| ARROW® 265169 - CORTICAL BONE SCREW, Ø4,5 L34 | 265169 - CORTICAL BONE SCREW, Ø4,5 L34 | 03661489651694 | — | On the market |
| ARROW® 265170 - CORTICAL BONE SCREW, Ø4,5 L36 | 265170 - CORTICAL BONE SCREW, Ø4,5 L36 | 03661489651700 | — | On the market |
| ARROW® 265171 - CORTICAL BONE SCREW, Ø4,5 L38 | 265171 - CORTICAL BONE SCREW, Ø4,5 L38 | 03661489651717 | — | On the market |
| ARROW® 265172 - CORTICAL BONE SCREW, Ø4,5 L40 | 265172 - CORTICAL BONE SCREW, Ø4,5 L40 | 03661489651724 | — | On the market |