| Primary Device ID | 00810005111225 |
| NIH Device Record Key | 0a333175-6b25-471b-af13-03192b27c439 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OrthoCircle Spine Pedicle Screw System |
| Version Model Number | RCTI035.S11 |
| Company DUNS | 040985864 |
| Company Name | OrthoCircle Spine |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810005111225 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2020-03-29 |
| 10810005111246 | Set Screw |
| 00810005111232 | Rod Curved 5.5mm x 30mm |
| 00810005111225 | Rod Curved 5.5mm x 35mm |
| 00810005111201 | Rod Curved 5.5mm x 45mm |
| 00810005111195 | Rod Curved 5.5mm x 55mm |
| 00810005111188 | Rod Curved 5.5mm x 50mm |
| 00810005111171 | Rod Curved 5.5mm x 65mm |
| 00810005111164 | Rod Curved 5.5mm x 60mm |
| 00810005111157 | Rod Curved 5.5mm x 70mm |
| 00810005111133 | Rod Curved 5.5mm x 80mm |
| 00810005111119 | Rod Curved 5.5mm x 90mm |
| 00810005111102 | Rod Curved 5.5mm x 100mm |
| 00810005110716 | 7.5 x 50mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110709 | 7.5 x 55mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110693 | 7.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110686 | 7.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110679 | 7.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110624 | 6.5 x 50mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110617 | 6.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110563 | 6.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110525 | 5.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110518 | 5.5 x 40mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110501 | 5.5 x 35mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110495 | 5.5 x 30mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110587 | 6.5 x 45mm Polyaxial-Non-Reduction Screw incl. Set Screw |
| 00810005110112 | 5.5mm Tap |
| 00810005110105 | 101.111 |
| 00810005110099 | Sounder - curved |
| 00810005110082 | Sounder - Straight |
| 00810005110075 | Pedicle Probe - Curved |
| 00810005110068 | Pedicle Probe - Straight |
| 00810005110051 | Pedicle Probe - Duck Bill |
| 00810005110044 | Palm Handle |
| 00810005110037 | Locking driver Shaft |
| 00810005110020 | Set Screw Driver |
| 00810005110013 | T-Handle - Ratcheting |
| 00810005110006 | Inline Handle - Ratcheting |
| 00810005110167 | Pistol Persuader |
| 00810005110150 | French Bender |
| 00810005110143 | Rod Fork |
| 00810005110136 | 7.5mm Tap |
| 00810005110129 | 6.5mm Tap |
| 00810005111645 | 60mm Rod Trial |
| 00810005111638 | Trial Rod Caddy |
| 00810005111614 | 50mm Rod Trial |
| 00810005110440 | 4.5 x 50mm Polyaxial-Non-Reduction Screw Set incl. Set Screw |
| 00810005110433 | 4.5 x 40mm Polyaxial-Non-Reduction Screw Set incl. Set Screw |
| 00810005110426 | 4.5 x 45mm Polyaxial-Non-Reduction Screw Set incl. Set Screw |
| 00810005110419 | 4.5 x 35mm Polyaxial-Non-Reduction Screw Set incl. Set Screw |
| 00810005110402 | 4.5 x 30mm Polyaxial-Non-Reduction Screw Set incl. Set Screw |