Pedicle Screw
- Primary DI
- B5231000025555
- Brand
- Pedicle Screw
- Company
- Eisertech, LLC
- Model
- 100002-5555C
- Catalog number
- 100002-5555C
- Device description
- CANNULATED MODULAR PEDICLE SCREW 5.5 X 55
- Published
- 2018-04-09
- 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 |
|---|---|---|---|---|
| B5231000025555 | Primary | HIBCC | 0 |
GMDN Terms
| Term | Definition |
|---|---|
| Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 965627297
- 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
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|---|---|---|---|---|
| B523100018121410 | Cervical Cage | 100018-121410 | 100018-121410 | 2017-04-06 |
| B52310001812144 | Cervical Cage | 100018-12144 | 100018-12144 | 2017-04-07 |
| B52310001812145 | Cervical Cage | 100018-12145 | 100018-12145 | 2017-04-07 |
| B52310001812146 | Cervical Cage | 100018-12146 | 100018-12146 | 2017-04-06 |
| B52310001812147 | Cervical Cage | 100018-12147 | 100018-12147 | 2017-04-06 |
| B52310001812148 | Cervical Cage | 100018-12148 | 100018-12148 | 2017-04-06 |
| B52310001812149 | Cervical Cage | 100018-12149 | 100018-12149 | 2017-04-06 |
| B523100018141610 | Cervical Cage | 100018-141610 | 100018-141610 | 2017-04-06 |
| B52310001814164 | Cervical Cage | 100018-14164 | 100018-14164 | 2017-04-06 |
| B52310001814165 | Cervical Cage | 100018-14165 | 100018-14165 | 2017-04-06 |
| B52310001814166 | Cervical Cage | 100018-14166 | 100018-14166 | 2017-04-06 |
| B52310001814167 | Cervical Cage | 100018-14167 | 100018-14167 | 2017-04-06 |
| B52310001814168 | Cervical Cage | 100018-14168 | 100018-14168 | 2017-04-06 |
| B52310001814169 | Cervical Cage | 100018-14169 | 100018-14169 | 2017-04-06 |
| B523100018161810 | Cervical Cage | 100018-161810 | 100018-161810 | 2017-04-06 |
| B52310001816184 | Cervical Cage | 100018-16184 | 100018-16184 | 2017-04-06 |
| B52310001816185 | Cervical Cage | 100018-16185 | 100018-16185 | 2017-04-07 |
| B52310001816186 | Cervical Cage | 100018-16186 | 100018-16186 | 2017-04-06 |
| B52310001816187 | Cervical Cage | 100018-16187 | 100018-16187 | 2017-04-06 |
| B52310001816188 | Cervical Cage | 100018-16188 | 100018-16188 | 2017-04-06 |
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