FDA UDI
In Commercial Distribution
🇺🇸 United States
CoNextions TR Tendon Repair System-Deployment Mechanism
DI: 00861445000310
·
Model: FA0002
·
CONEXTIONS MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CoNextions TR Tendon Repair System-Deployment Mechanism
- Primary DI
- 00861445000310
- Version / Model
- FA0002
- Catalog Number
- FA0002
- 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
- 1
- Public Version Date
- 2022-05-06
- Public Version Status
- New
- Public Device Record Key
- 84d3aaa6-b43c-4ff7-ab3f-1bfbb2a348e3
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 |
|---|---|---|---|---|
| 62523 | Tendon coaptation implant deployment tool | A sterile, hand-held, mechanical surgical instrument intended to be used to approximate the ends of a lacerated or ruptured tendon and to subsequently deploy a tendon coaptation implant in order to reattach the tendon ends. It is in the form of a stapler-like deployment gun with a proximal control used to deploy the distally-loaded implant. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10861445000317 | GS1 | 10-Pack | 10 | In Commercial Distribution | |
| Primary | 00861445000310 | GS1 |
Customer Contacts
- Phone
- (385) 351-1461
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K203855 | 000 |