Universal Mandible AXS
- Primary DI
- 37613327572088
- Brand
- Universal Mandible AXS
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 56-25003
- Catalog number
- 56-25003
- Device description
- Condylar Prosthesis fixation screws, AXS
- Published
- 2023-09-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| NEI | Prosthesis, condyle, mandibular, temporary |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NEI | Prosthesis, Condyle, Mandibular, Temporary | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K133285 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 37613327572088 | Primary | GS1 | 0 | |
| 07613327572087 | Unit of Use | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 37613327572088 | 37613327572088 | |
| 07613327572087 | 07613327572087 | 7613327572087 |
GMDN Terms#
| Term | Definition |
|---|---|
| Craniofacial bone screw, non-bioabsorbable | A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It 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 titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Length | 4.6 | Millimeter |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 316153956
- Device count
- 2
- 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 |
|---|---|---|---|---|
| 07613327572087 | Universal Mandible AXS | Stryker Leibinger GmbH & Co. KG | NEI | 2023-09-15 |
| 10888118131260 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2021-11-22 |
| 00888118131249 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2021-11-22 |
| 00888118131256 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2021-11-22 |
| 00888118131263 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2021-11-22 |
| 00888118113016 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2018-01-26 |
| 00888118073471 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 00888118073488 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 00888118073501 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 00888118073518 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 00888118073532 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 00888118073570 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 10888118073492 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 10888118073553 | LEVEL ONE CMF | KLS-Martin L.P. | NEI | 2016-03-24 |
| 00841036009830 | """2.4MM"" LOCKING RECON SYSTEM" | BIOMET MICROFIXATION, INC | NEI | 2015-10-11 |
| 00841036009847 | """2.4MM"" LOCKING RECON SYSTEM" | BIOMET MICROFIXATION, INC | NEI | 2015-10-11 |
| 00841036091507 | """2.4MM"" LOCKING RECON SYSTEM" | BIOMET MICROFIXATION, INC | NEI | 2015-10-11 |
| 34546540373985 | NA | Stryker Leibinger GmbH & Co. KG | NEI | 2015-09-24 |
| 04546540373991 | NA | Stryker Leibinger GmbH & Co. KG | NEI | 2015-09-24 |
| 04546540374004 | NA | Stryker Leibinger GmbH & Co. KG | NEI | 2015-09-24 |
| 10887587016382 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587016399 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587016405 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587016412 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587016429 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587016436 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587016443 | MatrixMANDIBLE | Synthes GmbH | NEI | 2015-09-14 |
| 10887587054537 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587054544 | NA | Synthes GmbH | NEI | 2015-09-14 |
| 10887587054551 | NA | Synthes GmbH | NEI | 2015-09-14 |