FDA UDI
In Commercial Distribution
🇺🇸 United States
MAXFRAME
DI: 10886982308641
·
Model: 03.312.002
·
SYNTHES (U.S.A.) LP
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MAXFRAME
- Primary DI
- 10886982308641
- Version / Model
- 03.312.002
- Catalog Number
- 03312002
- Company Name
- SYNTHES (U.S.A.) LP
- Labeler DUNS
- 832637081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-19
- Public Version
- 2
- Public Version Date
- 2021-12-22
- Public Version Status
- Update
- Public Device Record Key
- 69c0aae9-af98-4249-bcd5-d719097e7d14
Device Description
MAXFRAME(TM) 2.0 SOFTWARE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OSN | Software for diagnosis/treatment | Orthopedic | 888.3030 | 2 |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58120 | External orthopaedic fixation frame calculation software | A stand-alone software application designed provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth for fracture healing. This software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. It is intended to be installed on an off-the-shelf computer/smart device as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07612334226563 | GS1 | ||||
| Primary | 10886982308641 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211313 | 000 |