Rapidloc Ethibond
RAPIDLOC MENISCAL REPAIR-PLA TOPHAT / 27 Degrees Absorbable - PLA/PLA with Size 2/0 (3 metric) ETHIBOND Green braided polyester suture, and 27 Degrees curved needle
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | DePuy Mitek, Inc., United States |
|---|---|
| FDA product code | GAS |
| Device type | Suture, Nonabsorbable, Synthetic, Polyester |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K002406 |
| Record published | 2015-09-01 |
| Record revised | 2021-01-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 80 °F; Handling environment temperature up to 26 °C; Storage environment temperature up to 26 °C; Storage environment temperature up to 80 °F |
| Distribution end date | 2021-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 228422 | Withdrawn | |
| 228420 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atramat | Internacional Farmacéutica S.A DE C.V | 49 |
| TopLock | Fusion Orthopedics, LLC | 33 |
| RAM® COR-Suture® Quick Load® | LSI Solutions Inc. | 15 |
| A.C.S® (Alcon Closure System) | Alcon Laboratories, Inc. | 10 |
| Riverbond | Riverpoint Medical LLC | 7 |
| Polybond | Riverpoint Medical LLC | 6 |
| Fast-FIX | Smith & Nephew, Inc. | 3 |
| COR-Suture® Quick Load® | LSI Solutions Inc. | 2 |
| RD® Quick Load® | LSI Solutions Inc. | 2 |
| GII Ethibond | DePuy Mitek, Inc. | 2 |
| ALLthread Titanium | Biomet Orthopedics | 2 |
| Bioknotless Panacryl Ethibond | DePuy Mitek, Inc. | 1 |
Showing 12 of 16. All products under Suture, Nonabsorbable, Synthetic, Polyester
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880094 | 1989-09-22 | DACRON SURGICAL SUTURES | Alcon Laboratories, Inc. |
| P840041 | 1989-08-08 | NOVAFIL(TM) | Davis & Geck, Inc. |
| N83509 | 1987-02-20 | NON-ABSORBABLE (POLYESTER FIBER) SUTURES | Davis & Geck, Inc. |
| N17809 | 1986-12-03 | ETHIBOND* | Ethicon, Inc. |
| N80950 | 1985-03-22 | POLYVIOLENE SUTURE | Look, Inc. |
| N17804 | 1984-03-27 | ETHIBOND* | Ethicon, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.