FDA UDI
In Commercial Distribution
🇺🇸 United States
CoNextions TR Tendon Repair System-Implant Mechanism
DI: 00861445000327
·
Model: FA0004
·
CONEXTIONS MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CoNextions TR Tendon Repair System-Implant Mechanism
- Primary DI
- 00861445000327
- Version / Model
- FA0004
- Catalog Number
- FA0004
- Company Name
- CONEXTIONS MEDICAL INC
- Labeler DUNS
- 063692935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-28
- Public Version
- 2
- Public Version Date
- 2023-08-31
- Public Version Status
- Update
- Public Device Record Key
- 26603f1a-e9e2-427d-9d26-ee09675af79e
Device Description
The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | General, Plastic Surgery | 878.4495 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62522 | Tendon coaptation implant | A sterile, implantable, non-bioabsorbable device intended to be used to reattach the ends of a lacerated or ruptured tendon in order to repair the tendon and restore its function. It is in the form of small suture-like wires made of metal and synthetic polymer materials, and is permanently implanted into the tendon ends with a dedicated stapler-like tool. Disposable devices intended to assist implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10861445000324 | GS1 | 1 | 10 | In Commercial Distribution | |
| Primary | 00861445000327 | GS1 |
Customer Contacts
- Phone
- (385) 351-1461
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203855 | 000 |