L2L™
48 catalogue numbers from 00-8700-007-04, listed by Zimmer, Inc., United States, under Prosthesis, Elbow, Hemi-, Radial, Polymer. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
48catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | KWI |
| Device type | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3170 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2017-11-09 |
| Record revised | 2018-03-29 (version 2) |
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 |
| Sizes | Height 9 to 14 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-8700-007-04 | +4 mm Height | In distribution |
| 00-8700-009-04 | +4 mm Height | In distribution |
| 00-8700-010-02 | +2 mm Height | In distribution |
| 00-8700-005-04 | 5 mm Diameter, +4 mm Height | In distribution |
| 00-8700-001-22 | 22 mm Diameter | In distribution |
| 00-8700-007-00 | +0 mm Height | In distribution |
| 00-8700-005-02 | 5 mm Diameter | In distribution |
| 00-8700-005-00 | 5 mm Diameter, +0 mm Height | In distribution |
| 00-8700-009-00 | +0 mm Height | In distribution |
| 00-8700-007-04 | 7 mm Diameter, +4 mm Height | In distribution |
| 00-8700-006-00 | 6 mm Diameter, +0 mm Height | In distribution |
| 00-8700-001-18 | 18 mm Diameter | In distribution |
| 00-8700-008-00 | +0 mm Height | In distribution |
| 00-8700-007-00 | 7 mm Diameter, +0 mm Height | In distribution |
| 00-8700-007-02 | +2 mm Height | In distribution |
| 00-8700-008-04 | +4 mm Height | In distribution |
| 00-8700-001-20 | Height 10.00 mm | In distribution |
| 00-8700-001-28 | Height 14 mm | In distribution |
| 00-8700-001-22 | 22 mm Diameter | In distribution |
| 00-8700-009-02 | +2 mm Height | In distribution |
| 00-8700-001-18 | 18 mm Diameter | In distribution |
| 00-8700-005-04 | 5 mm Diameter | In distribution |
| 00-8700-001-26 | Height 13 mm | In distribution |
| 00-8700-001-26 | Height 13.00 mm | In distribution |
| 00-8700-005-02 | 5 mm Diameter, +2 mm Height | In distribution |
| 00-8700-001-28 | Height 14.00 mm | In distribution |
| 00-8700-008-04 | 8 mm Diameter, +4 mm Height | In distribution |
| 00-8700-009-02 | 9 mm Diameter, +2 mm Height | In distribution |
| 00-8700-008-02 | +2 mm Height | In distribution |
| 00-8700-005-00 | 5 mm Diameter | In distribution |
| 00-8700-008-02 | 8 mm Diameter, +2 mm Height | In distribution |
| 00-8700-006-02 | +2 mm Height | In distribution |
| 00-8700-006-04 | 6 mm Diameter, +4 mm Height | In distribution |
| 00-8700-010-00 | 10 mm Diameter, +0 mm Height | In distribution |
| 00-8700-010-04 | 10 mm Diameter, +4 mm Height | In distribution |
| 00-8700-001-24 | Height 12.00 mm | In distribution |
| 00-8700-009-00 | 9 mm Diameter, +0 mm Height | In distribution |
| 00-8700-006-00 | 6 mm Diameter | In distribution |
| 00-8700-001-20 | 20 mm Diameter | In distribution |
| 00-8700-010-00 | +0 mm Height | In distribution |
| 00-8700-006-02 | 6 mm Diameter, +2 mm Height | In distribution |
| 00-8700-006-04 | +4 mm Height | In distribution |
| 00-8700-010-04 | +4 mm Height | In distribution |
| 00-8700-010-02 | 10 mm Diameter, +2 mm Height | In distribution |
| 00-8700-007-02 | 7 mm Diameter, +2 mm Height | In distribution |
| 00-8700-001-24 | 24 mm Diameter | In distribution |
| 00-8700-009-04 | 9 mm Diameter, +4 mm Height | In distribution |
| 00-8700-008-00 | 8 mm Diameter, +0 mm Height | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acumed | Acumed LLC | 175 |
| Align | Skeletal Dynamics L.L.C. | 97 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes (U.S.A.) LP | 78 |
| Evolve | Wright Medical Technology, Inc. | 75 |
| Rhead | Stryker GmbH | 53 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | Synthes Gmbh | 43 |
| Explor | Biomet Orthopedics | 32 |
| Avenger | IN2BONES USA, LLC | 32 |
| BioPoly® Radial Head Implant | Biopoly, LLC | 30 |
| Seitz Solution Radial Head | Kapp Surgical Instrument, Inc. | 27 |
| Integra® | Ascension Orthopedics, Inc. | 23 |
| Modular Radial Head (MRH) System | Smith & Nephew, Inc. | 22 |
Showing 12 of 28. All products under Prosthesis, Elbow, Hemi-, Radial, Polymer
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.