SAS PI-Rod
- Primary DI
- 00850075160259
- Brand
- SAS PI-Rod
- Company
- SPINAL ALIGNMENT SOLUTIONS, INC.
- Model
- 1
- Catalog number
- PI506055TIL4S1
- Device description
- PI RANGE 50-60 - L4S1 - 5.5DIA
- Published
- 2026-02-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00850075160259 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00850075160259 | 00850075160259 | 850075160259 | 0850075160259 |
GMDN Terms
| Term | Definition |
|---|---|
| Bone-screw internal spinal fixation system rod | An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 107603593
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850075160006 | SAS PI-Rod | 1 | FGN-408055TI | 2026-02-16 |
| 00850075160013 | SAS PI-Rod | 1 | FGN-004055TI | 2026-02-16 |
| 00850075160020 | SAS PI-Rod | 1 | FGN-405055TI | 2026-02-16 |
| 00850075160037 | SAS PI-Rod | 1 | FGN-506055TI | 2026-02-16 |
| 00850075160044 | SAS PI-Rod | 1 | FGN-607055TI | 2026-02-16 |
| 00850075160051 | SAS PI-Rod | 1 | FGN-708055TI | 2026-02-16 |
| 00850075160068 | SAS PI-Rod | 1 | FGN-800055TI | 2026-02-16 |
| 00850075160075 | SAS PI-Rod | 1 | PI004055TIL1S1 | 2026-02-16 |
| 00850075160082 | SAS PI-Rod | 1 | PI004055TIL3S1 | 2026-02-16 |
| 00850075160099 | SAS PI-Rod | 1 | PI004055TIL3L5 | 2026-02-16 |
| 00850075160105 | SAS PI-Rod | 1 | PI004055TIL3L4 | 2026-02-16 |
| 00850075160112 | SAS PI-Rod | 1 | PI004055TIL4S1 | 2026-02-16 |
| 00850075160129 | SAS PI-Rod | 1 | PI004055TIL4L5 | 2026-02-16 |
| 00850075160136 | SAS PI-Rod | 1 | PI004055TIL5S1 | 2026-02-16 |
| 00850075160143 | SAS PI-Rod | 1 | PI405055TIL3S1 | 2026-02-16 |
| 00850075160150 | SAS PI-Rod | 1 | PI405055TIL3S1 | 2026-02-16 |
| 00850075160167 | SAS PI-Rod | 1 | PI405055TIL3L5 | 2026-02-16 |
| 00850075160174 | SAS PI-Rod | 1 | PI405055TIL3L4 | 2026-02-16 |
| 00850075160181 | SAS PI-Rod | 1 | PI405055TIL4S1 | 2026-02-16 |
| 00850075160198 | SAS PI-Rod | 1 | PI405055TIL4L5 | 2026-02-16 |
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|---|---|---|---|---|
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| 00840185382573 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382580 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 00840185382597 | 4CIS WILL PEDICLE SCREW SYSTEM | SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED | NKB | 2026-05-25 |
| 07290014381254 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290014381261 | ProMIS™ Fixation System | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 07290115935615 | Counter Torque ST | PREMIA SPINE LTD | NKB | 2026-05-25 |
| 06941312465757 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
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| 06941312465887 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465894 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465900 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-24 |
| 06941312465559 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465566 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465573 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465580 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465597 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465603 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465610 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465627 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |
| 06941312465634 | Sterile Posterior Spinal Fixation System | Shanghai Reach Medical Instrument Co., Ltd | NKB | 2026-05-22 |