NA
- Primary DI
- 07613327504415
- Brand
- NA
- Company
- Stryker Leibinger GmbH & Co. KG
- Model
- 92-02322
- Catalog number
- 92-02322
- Published
- 2020-05-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| MQN | EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MQN | External Mandibular Fixator And/Or Distractor | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K181504 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07613327504415 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07613327504415 | 07613327504415 | 7613327504415 |
GMDN Terms#
| Term | Definition |
|---|---|
| Implantable craniofacial bone distractor | An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 | |
| Height | 5 | Millimeter |
| Length | 60 | Millimeter |
| Width | 15 | Millimeter |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 316153956
- Device count
- 1
- Lot or batch
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07613327694482 | DELTA | 70-92345 | 70-92345 | 2026-07-21 |
| 07613327694499 | DELTA | 70-92350 | 70-92350 | 2026-07-21 |
| 04546540356703 | NA | 62-23501 | 62-23501 | 2016-12-08 |
| 04546540356710 | NA | 64-00175 | 64-00175 | 2016-12-08 |
| 04546540356727 | NA | 64-00176 | 64-00176 | 2016-12-08 |
| 04546540366818 | NA | 62-92023 | 62-92023 | 2016-10-19 |
| 07613154184026 | NA | 62-00316 | 62-00316 | 2016-12-08 |
| 07613154185450 | NA | 62-00315 | 62-00315 | 2016-12-08 |
| 04546540246974 | NA | 60-15486 | 60-15486 | 2016-08-24 |
| 04546540246981 | NA | 60-15496 | 60-15496 | 2016-08-24 |
| 04546540251862 | NA | 60-80142 | 60-80142 | 2016-08-24 |
| 04546540287168 | NA | 6514-4-180 | 6514-4-180 | 2016-12-08 |
| 04546540356499 | NA | 60-16005 | 60-16005 | 2016-08-24 |
| 04546540356505 | NA | 60-16007 | 60-16007 | 2016-08-24 |
| 04546540356512 | NA | 60-16035 | 60-16035 | 2016-08-24 |
| 04546540356529 | NA | 60-16050 | 60-16050 | 2016-08-24 |
| 04546540356536 | NA | 60-19035 | 60-19035 | 2016-08-24 |
| 04546540356543 | NA | 60-20050 | 60-20050 | 2016-08-24 |
| 04546540356567 | NA | 60-94120 | 60-94120 | 2016-08-24 |
| 04546540356628 | NA | 62-00302 | 62-00302 | 2016-12-08 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00888118108685 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2017-08-17 |
| 00888118006189 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118006202 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118006226 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118007261 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118007278 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118032812 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118037480 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118037503 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118037510 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118039439 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118039446 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044457 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044471 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044495 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044518 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044532 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044556 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044631 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044655 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118044679 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045010 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045034 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045058 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045072 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045096 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045119 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045133 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045195 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |
| 00888118045485 | LEVEL ONE CMF | KLS-Martin L.P. | MQN | 2016-03-24 |