Noras or Head Holder
by Siemens Medical Solutions USA, Inc.
510(k) K071179
Noras or Head Holder is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K071179 on 13 Jun 2007, 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 | NumberK071179 | Date13 Jun 2007 | StatusActive |
Official records
- FDA 510(k) database K071179
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MOS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K071179
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 | |||
|---|---|---|---|---|
| 5 Pin Bolt Wrench (Ball Handle) 02 | 113048 / 02 | 04251269205361 | On the market | |
| 5 Pin Bolt Wrench small 01 | 112996 / 01 | 04251269200755 | On the market | |
| 5 Pin Bolt Wrench small 02 | 112996 / 02 | 04251269205347 | On the market | |
| All-Purpose Arch 02 | 113393 / 02 | 04251269205668 | On the market | |
| All-Purpose Arch Adapter 01 | 113397 / 01 | 04251269201080 | On the market | |
| All-Purpose Arch Set 01 | 113220 / 01 | 04251269201066 | On the market | |
| All-Purpose Arch Set 02 | 113220 / 02 | 04251269205682 | On the market | |
| Base Plate Miyabi 1 | 113053 / 1 | 04251269204814 | On the market | |
| Base Plate Trumpf Shell Heidberg II 1 | 119897 / 1 | 04251269204784 | On the market | |
| Brainlab Interface Rotating, with Marking 01 | 113382 / 01 | 04251269204715 | On the market | |
| C-Arc Holder Trumpf Shell Heidberg II 01 | 119533 / 01 | 04251269204791 | On the market | |
| C-Arc Holder, Adjustable in Height 02 | 111858 / 02 | 04251269203336 | On the market | |
| Clamp 01 | 114126 / 01 | 04251269200793 | On the market | |
| Clamping Device 03 | 114232 / 03 | 04251269205415 | On the market | |
| Clamping Screw short 01 | 117684 / 01 | 04251269201059 | On the market | |
| Cleaning, Disinfection and Sterilization Instructions 02 | 117904 / 02 | 04251269200700 | On the market | |
| Coil Fixation Block 01 | 112701 / 01 | 04251269200854 | On the market | |
| Coil Fixation Plate 65mm 01 | 112696 / 01 | 04251269200861 | On the market | |
| Coil-Column, short 01 | 01 | 04251269204753 | On the market | |
| Drape Link Adapter II 01 | 118523 / 01 | 04251269200588 | On the market | |
| GREENBERG Retractor Adapter 01 | 114295 / 01 | 04251269201097 | On the market | |
| Head Frame Cushion 01 | 118166 / 01 | 04251269200717 | On the market | |
| Head Frame Cushion 02 | 118166 / 02 | 04251269205163 | On the market | |
| Head Frame Heidberg 03 | 117262 / 03 | 04251269203305 | On the market | |
| Head Frame Heidberg Refurbished 02 | 119061 / 02 | 04251269203329 | On the market | |
| Hexagon Socket Wrench 5mm for Miyabi Shell 01 | 113062 / 01 | 04251269200533 | On the market | |
| Hexagon Socket Wrench 5mm for Miyabi Shell 02 | 113062 / 02 | 04251269205354 | On the market | |
| LEYLA Retractor Socket 01 | 113243 / 01 | 04251269201103 | On the market | |
| LEYLA Retractor Socket 02 | 113243 / 02 | 04251269205392 | On the market | |
| lock release 01 | 118510 / 01 | 04251269204883 | On the market | |
| Manual - NORAS OR Head Holder Upgrade Kit "Heiberg" 01 | 117485 / 01 | 04251269204692 | On the market | |
| Maquet Screw Tool 01 | 113064 / 01 | 04251269200786 | On the market | |
| Multi-purpose Screw 01 | 112390 / 01 | 04251269200823 | On the market | |
| NORAS OR Head Holder Upgrade Kit Heidberg 02 | 114809 / 02 | 04251269203275 | On the market | |
| Nut for Ball Joint 01 | 111884 / 01 | 04251269203930 | On the market | |
| Pediatric Set 01 | 114804 / 01 | 04251269200045 | On the market | |
| Phantom holder compl. 01 | 113598 / 01 | 04251269202537 | On the market | |
| pillow, Maquet Transfer Board 01 | 113198 / 01 | 04251269204760 | On the market | |
| Pin Holder with Lock Nut, large 01 | 114352 / 01 | 04251269200991 | On the market | |
| Pin Holder, XS 01 | 111884 / 01 | 04251269204630 | On the market | |
| Screw for Ball Joint 01 | 111885 / 01 | 04251269203923 | On the market | |
| Screw for Ball Joint II 01 | 119536 / 01 | 04251269204807 | On the market | |
| Screw for C-Arc 01 | 111855 / 01 | 04251269204869 | On the market | |
| Screw for Clamp 01 | 113049 / 01 | 04251269200878 | On the market | |
| Screw for Miyabi OR Table 01 | 113050 / 01 | 04251269201042 | On the market | |
| Skull Pin with big tip 01 | 114096 / 01 | 04251269201028 | On the market | |
| Skull Pin with small tip Flexibility 01 | 117329 / 01 | 04251269201134 | On the market | |
| Socket Wrench 03 | 113065 / 03 | 04251269200137 | On the market | |
| Socket Wrench 04 | 113065 / 04 | 04251269205408 | On the market | |
| Universal Angle Bracket 01 | 113920 / 01 | 04251269200762 | On the market |
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