FDA UDI
In Commercial Distribution
🇺🇸 United States
DUALX TRIAL QUICK RELEASE TORQUE PIN
DI: B707125342160
·
Model: 12534216
·
Amplify Surgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DUALX TRIAL QUICK RELEASE TORQUE PIN
- Primary DI
- B707125342160
- Version / Model
- 12534216
- Company Name
- Amplify Surgical, Inc.
- Labeler DUNS
- 081021000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-07
- Public Version
- 1
- Public Version Date
- 2021-06-15
- Public Version Status
- New
- Public Device Record Key
- 528636ce-eb53-4c5b-a1ff-9db335e2c8c2
Device Description
DUALX TRIAL QUICK RELEASE TORQUE PIN
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
- Yes
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12696 | Orthopaedic implant inserter/extractor, reusable | A hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B707125342160 | HIBCC |
Customer Contacts
- Phone
- 7652675439
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181397 | 000 |