Instrument
Restoration ADM Trial Insert 28/50- NOT Compatible With MDM
5manufacturers in China registered for this device type
100catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | MBL |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2024-05-10 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Outer diameter 38 to 79 mm; lumen/inner diameter 22 to 58 mm; length 25 to 30 mm |
| Distribution end date | 2023-10-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6264-8-144R | Offset: 0.0 Millimeter | In distribution |
| 1020-5103 | Size: 3 | In distribution |
| 2102-0466 | Diameter: 66.0 Millimeter | In distribution |
| 1235-0-006A | In distribution | |
| 2102-0478 | Diameter: 78.0 Millimeter | In distribution |
| 1235-V-0027 | Offset: -2.7 Millimeter | In distribution |
| 1030-3258 | Outer Diameter 58.0 mm | In distribution |
| 2102-0452 | Diameter: 52.0 Millimeter | In distribution |
| 6278-8-317 | Diameter: 17.0 Millimeter | In distribution |
| I-H2108ER62 | Diameter: 62.0 Millimeter | In distribution |
| 2102-0444 | Diameter: 44.0 Millimeter | In distribution |
| 1020-3240 | Degree: 132.0 Degree | In distribution |
| 1101-0304 | In distribution | |
| 2200-22F | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2208-4045 | Diameter: 45.0 Millimeter | In distribution |
| 1235-0-850 | In distribution | |
| I-H1862HB03 | Size: 3 | In distribution |
| 2210-32J | Degree: 10.0 Degree | In distribution |
| 1440-1400 | In distribution | |
| I-H2108EC00 | In distribution | |
| 2102-0442 | Diameter: 42.0 Millimeter | In distribution |
| 4845-2-967 | Size: 7 | In distribution |
| 6264-8-428R | Offset: 12.0 Millimeter | In distribution |
| 2240-28J | Alpha Code: J | In distribution |
| 6825-2-238 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 2208-4048S | Diameter: 48.0 Millimeter | In distribution |
| I-H2154RG12 | In distribution | |
| 6264-8-236R | Taper Connection: V40? | In distribution |
| 5097-0800 | In distribution | |
| I-H1382H140 | Taper Connection: V40? | In distribution |
| 1110-0507 | In distribution | |
| 2208-6069R | Side: RIGHT | In distribution |
| 6264-8-928R | Head Diameter: 28.0 Millimeter | In distribution |
| 3200-58J | Alpha Code: J | In distribution |
| 1100-3675R | Head Diameter: 36.0 Millimeter | In distribution |
| I-H2116OH0R | In distribution | |
| 1030-2250 | Outer Diameter 50.0 mm | In distribution |
| 1601-36127 | Degree: 127.0 Degree | In distribution |
| 1235-4-545 | In distribution | |
| 2101-0200 | In distribution | |
| I-H2108ER64 | Diameter: 64.0 Millimeter | In distribution |
| 1235-0-622 | Outer Diameter 62.0 mm | In distribution |
| 2111-0040 | Diameter: 40.0 Millimeter | In distribution |
| 4845-2-952 | Size: 2 | In distribution |
| 2210-28D | Alpha Code: D | In distribution |
| I-H1382H244 | Diameter: 44.0 Millimeter | In distribution |
| 6278-8-325 | Diameter: 25.0 Millimeter | In distribution |
| 0939-2-100 | In distribution | |
| 1601-1100 | In distribution | |
| 1601-1531 | Size: Standard | In distribution |
| 2240-32I | Degree: 0.0 Degree | In distribution |
| 1100-2605R | Head Diameter: 26.0 Millimeter | In distribution |
| 1020-5104 | Size: 4 | In distribution |
| 1235-0-860M | In distribution | |
| I-H2085RG35 | Neck Length: 35.0 Millimeter | In distribution |
| 1150-2348 | Outer Diameter 48.0 mm | In distribution |
| 1111-1001 | Size: SM | In distribution |
| 2199-2022 | Diameter: 22.0 Millimeter | In distribution |
| 5097-4620 | Thickness: 20.0 Millimeter | In distribution |
| 2208-6079L | Side: LEFT | In distribution |
| 1100-3610R | Head Diameter: 36.0 Millimeter | In distribution |
| 6825-9-948 | Outer Diameter 48.0 mm | In distribution |
| 1235-C-0025 | Offset: -2.5 Millimeter | In distribution |
| 6278-8-318 | Diameter: 18.0 Millimeter | In distribution |
| 6278-8-313 | Diameter: 13.0 Millimeter | In distribution |
| 1100-4400R | Head Diameter: 44.0 Millimeter | In distribution |
| 2200-32C | Diameter: 32.0 Millimeter | In distribution |
| 4845-2-956 | Side: RIGHT | In distribution |
| 2102-0455 | Diameter: 55.0 Millimeter | In distribution |
| 1118-1005 | In distribution | |
| 1150-2358 | Outer Diameter 58.0 mm | In distribution |
| 6278-8-316 | Diameter: 16.0 Millimeter | In distribution |
| 1235-0-862M | In distribution | |
| 2200-40I | Alpha Code: I | In distribution |
| 2210-32D | Alpha Code: D | In distribution |
| 1150-2340 | Outer Diameter 40.0 mm | In distribution |
| 0932-0-000 | Size: SM | In distribution |
| 0939-1-116M | Thickness: 16.0 Millimeter | In distribution |
| 4845-5-520 | In distribution | |
| 1030-2642 | Lumen/Inner Diameter 26.0 mm | In distribution |
| 2102-0480 | Diameter: 80.0 Millimeter | In distribution |
| 2107-1016 | In distribution | |
| 1100-1225S | Length 25.0 mm | In distribution |
| 2240-32J | Lumen/Inner Diameter 32.0 mm | In distribution |
| 0939-1-106M | Thickness: 6.0 Millimeter | In distribution |
| 6825-9-946 | Outer Diameter 46.0 mm | In distribution |
| 6264-8-228R | Taper Connection: V40? | In distribution |
| 2102-0447 | Diameter: 47.0 Millimeter | In distribution |
| 2250-28C | Degree: 10.0 Degree | In distribution |
| 1030-2246 | Lumen/Inner Diameter 22.0 mm | In distribution |
| 1601-1400 | Size: Standard | In distribution |
| 1150-2356 | Outer Diameter 56.0 mm | In distribution |
| I-H0659HA45 | Diameter: 45.0 Millimeter | Withdrawn |
| I-H1268TH00 | Diameter: 36.0 Millimeter | Withdrawn |
| I-H0789HA30 | Diameter: 4.0 Millimeter | Withdrawn |
| I-H2148HF00 | Withdrawn | |
| I-H0659HA72 | Diameter: 72.0 Millimeter | Withdrawn |
| I-H08452065 | Diameter: 65.0 Millimeter | Withdrawn |
| I-H0659HA39 | Diameter: 39.0 Millimeter | Withdrawn |
| I-H0789HA25 | Diameter: 4.0 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| R3 | Smith & Nephew, Inc. | 177 |
| Reflection | Smith & Nephew, Inc. | 89 |
| Profemur® | Microport Orthopedics Inc. | 53 |
| Delta | Limacorporate | 44 |
| Onvoy | Globus Medical, Inc. | 40 |
| Restoration | Howmedica Osteonics Corp | 39 |
| Dynasty | Microport Orthopedics Inc. | 28 |
| Delta Liners & Accessories | Limacorporate | 27 |
| R3, Stiktite | Smith & Nephew, Inc. | 26 |
| Biolox Delta | Limacorporate | 19 |
| Tri-plus | Ortho Development Corp. | 16 |
| Trident | Howmedica Osteonics Corp | 15 |
Showing 12 of 96. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
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.