MBA™
- Primary DI
- M248MBASET1
- Brand
- MBA™
- Company
- Ascension Orthopedics, Inc.
- Model
- MBASET
- Device description
- MBA™ Instrument Set (05-5000)
- Published
- 2016-07-25
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Contact Domains#
integralife.comProduct Codes#
| Code | Name |
|---|---|
| HWC | Screw, fixation, bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K051611 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780257288 | Primary | GS1 | 0 | |
| M248MBASET1 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780257288 | 10381780257288 |
GMDN Terms#
| Term | Definition |
|---|---|
| Subtalar implant, non-bioabsorbable, sterile | A sterile device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE). |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 942377524
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- 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
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10381780240204 | Cadence™ | 10203022 | 2016-08-24 | |
| 10381780240211 | Cadence™ | 10203023 | 10203023 | 2016-08-24 |
| 10381780240228 | Cadence™ | 10203024 | 10203024 | 2016-08-24 |
| 10381780240235 | Cadence™ | 10203025 | 2016-08-24 | |
| 10381780240242 | Cadence™ | 10203026 | 2016-08-24 | |
| 10381780240754 | Cadence™ | 10204202 | 10204202 | 2016-08-24 |
| 10381780245612 | Titan™ | IMC096004301 | IMC-0960-043-01 | 2017-08-30 |
| 10381780246374 | Integra® | OSG20000 | OSG-200-00 | 2017-08-30 |
| 10381780246381 | Integra® | OSG20010P | OSG-200-10P | 2017-08-30 |
| 10381780246398 | Integra® | OSG20010PV | OSG-200-10PV | 2017-08-30 |
| 10381780246404 | Integra® | OSG20020P | OSG-200-20P | 2017-08-30 |
| 10381780246411 | Integra® | OSG20020PV | OSG-200-20PV | 2017-08-30 |
| 10381780246428 | Integra® | OSG20030P | OSG-200-30P | 2017-08-30 |
| 10381780246435 | Integra® | OSG20030PV | OSG-200-30PV | 2017-09-05 |
| 10381780246442 | Integra® | OSG20040P | OSG-200-40P | 2017-09-05 |
| 10381780246459 | Integra® | OSG20040PV | OSG-200-40PV | 2017-08-30 |
| 10381780246466 | Integra® | OSG35001 | OSG-350-01 | 2017-08-30 |
| 10381780246473 | Integra® | OSG44200 | OSG-442-00 | 2017-09-05 |
| 10381780246480 | First Choice® DRUJ System | OSG60000 | OSG-600-00 | 2017-09-05 |
| 10381780246497 | First Choice® DRUJ System | OSG60001 | OSG-600-01 | 2017-09-05 |
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