AXS
- Primary DI
- 37613327358378
- Brand
- AXS
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 56-17905
- Catalog number
- 56-17905
- Device description
- BONE SCREWS, AXS, SELF-DRILLING
- Published
- 2017-11-18
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| JEY | PLATE, BONE |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JEY | Plate, Bone | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K172572 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 37613327358378 | Primary | GS1 | 0 | |
| 07613327358377 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 37613327358378 | 37613327358378 | |
| 07613327358377 | 07613327358377 | 7613327358377 |
GMDN Terms#
| Term | Definition |
|---|---|
| Craniofacial bone screw, non-bioabsorbable, non-sterile | A small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Length | 5 | Millimeter |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 316153956
- Device count
- 5
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07613327300086 | NA | 78-80020 | 78-80020 | 2021-01-27 |
| 07613327300109 | NA | 78-80040 | 78-80040 | 2021-01-27 |
| 07613327300123 | NA | 78-80030 | 78-80030 | 2021-01-27 |
| 04546540730763 | NA | 78-10010 | 78-10010 | 2015-07-03 |
| 04546540730787 | NA | 78-10030 | 78-10030 | 2015-07-03 |
| 04546540730794 | NA | 78-10040 | 78-10040 | 2015-07-03 |
| 04546540730800 | NA | 78-10100 | 78-10100 | 2015-07-03 |
| 07613327004021 | NA | 78-10020 | 78-10020 | 2015-07-03 |
| 07613327129236 | NA | 78-40010 | 78-40010 | 2015-09-24 |
| 07613327129243 | NA | 78-40100 | 78-40100 | 2015-09-24 |
| 07613327129250 | NA | 78-40040 | 78-40040 | 2015-09-24 |
| 07613327129267 | NA | 78-50030 | 78-50030 | 2015-09-24 |
| 07613327129274 | NA | 78-50040 | 78-50040 | 2015-09-24 |
| 07613327129281 | NA | 78-50020 | 78-50020 | 2015-09-24 |
| 07613327129298 | NA | 78-40030 | 78-40030 | 2015-09-24 |
| 07613327129328 | NA | 78-50010 | 78-50010 | 2015-09-24 |
| 07613327129335 | NA | 78-40020 | 78-40020 | 2015-09-24 |
| 07613327300017 | NA | 78-70020 | 78-70020 | 2017-02-21 |
| 07613327300031 | NA | 78-70040 | 78-70040 | 2017-02-21 |
| 07613327300055 | NA | 78-70030 | 78-70030 | 2017-02-21 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04046826346812 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | JEY | 2026-06-25 |
| 04046826416676 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | JEY | 2026-06-25 |
| 04046826542337 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | JEY | 2026-06-25 |
| 04046826543655 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | JEY | 2026-06-25 |
| 04046826552473 | Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | JEY | 2026-06-25 |
| 00888118126528 | LEVEL ONE CMF, STERILE | KLS-Martin L.P. | JEY | 2020-04-22 |
| 10888118113600 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2017-10-20 |
| 10888118113617 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2017-10-20 |
| 00888118001825 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118001870 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118002129 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118002136 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003041 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003058 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003751 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003775 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003782 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003799 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003805 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003935 | LEVEL ONE NEURO | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003942 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118003959 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118004840 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118005298 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118005304 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118005311 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118005441 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118005458 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118005571 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |
| 00888118005588 | LEVEL ONE CMF | KLS-Martin L.P. | JEY | 2016-03-24 |