Primary Device ID | 00812352021301 |
NIH Device Record Key | 65012e35-d54b-4b53-b0bd-dae9fc369c23 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Royal Oak Pedicle Screw System |
Version Model Number | 4301081 |
Company DUNS | 017825896 |
Company Name | Royal Oak Medical Devices 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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
00812352021318 | Royal Oak Pedicle Screw Instrument Set Case 2 |
00812352021301 | Royal Oak Pedicle Screw Instrument Set Case 1 |
00812352020564 | Straight Rod Ø5.5x90mm |
00812352020557 | Straight Rod Ø5.5x80mm |
00812352020540 | Straight Rod Ø5.5x70mm |
00812352020533 | Straight Rod Ø5.5x50mm |
00812352020526 | Straight Rod Ø5.5 x 400mm |
00812352020519 | Straight Rod Ø5.5x40mm |
00812352020502 | Straight Rod Ø5.5x200mm |
00812352020496 | Straight Rod Ø5.5x180mm |
00812352020489 | Straight Rod Ø5.5x150mm |
00812352020472 | Straight Rod Ø5.5x120mm |
00812352020465 | Straight Rod Ø5.5x110mm |
00812352020458 | Straight Rod Ø5.5x100mm |
00812352020441 | 5.5mm Pedicle Screw Assembly Ø7.5x55mm |
00812352020434 | 5.5mm Pedicle Screw Assembly Ø7.5x50mm |
00812352020427 | 5.5mm Pedicle Screw Assembly Ø7.5x45mm |
00812352020410 | 5.5mm Pedicle Screw Assembly Ø7.5x40mm |
00812352020403 | 5.5mm Pedicle Screw Assembly Ø7.5x35mm |
00812352020397 | 5.5mm Pedicle Screw Assembly Ø7.5x30mm |
00812352020380 | 5.5mm Pedicle Screw Assembly Ø6.5x55mm |
00812352020373 | 5.5mm Pedicle Screw Assembly Ø6.5x50mm |
00812352020366 | 5.5mm Pedicle Screw Assembly Ø6.5x45mm |
00812352020359 | 5.5mm Pedicle Screw Assembly Ø6.5x40mm |
00812352020342 | 5.5mm Pedicle Screw Assembly Ø6.5x35mm |
00812352020335 | 5.5mm Pedicle Screw Assembly Ø6.5x30mm |
00812352020328 | 5.5mm Pedicle Screw Assembly Ø5.5x50mm |
00812352020311 | 5.5mm Pedicle Screw Assembly Ø5.5x45mm |
00812352020304 | 5.5mm Pedicle Screw Assembly Ø5.5x40mm |
00812352020298 | 5.5mm Pedicle Screw Assembly Ø5.5x35mm |
00812352020281 | 5.5mm Pedicle Screw Assembly Ø4.5x50mm |
00812352020274 | 5.5mm Pedicle Screw Assembly Ø4.5x45mm |
00812352020267 | 5.5mm Pedicle Screw Assembly Ø4.5x40mm |
00812352020250 | 5.5mm Pedicle Screw Assembly Ø4.5x35mm |
00812352020243 | 5.5mm Pedicle Screw Assembly Ø4.5x30mm |
00812352020236 | Curved Rod Ø5.5 x 90 mm |
00812352020229 | Curved Rod Ø5.5 x 80 mm |
00812352020212 | Curved Rod Ø5.5 x 70 mm |
00812352020205 | Curved Rod Ø5.5 x 60 mm |
00812352020199 | Curved Rod Ø5.5 x 50 mm |
00812352020182 | Curved Rod Ø5.5 x 45 mm |
00812352020175 | Curved Rod Ø5.5 x 40 mm |
00812352020168 | Cross Connector, Variable, 58-80mm |
00812352020151 | Cross Connector, Variable, 48-60mm |
00812352020144 | Cross Connector, Variable, 43-50mm |
00812352020137 | Cross Connector, Variable, 40-45mm |
00812352020120 | Cross Connector, Fixed 40mm |
00812352020113 | Cross Connector, Fixed 37mm |
00812352020106 | Cross Connector, Fixed 34mm |
00812352020090 | Cross Connector, Fixed 31mm |