Focus
Pedicle screw cross connect holder Class 1 instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and…
Pedicle screw cross connect holder Class 1 instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
Who Else Makes It
Concentrated in Zhejiang (31), Jiangsu (27), Guangdong (20). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
Showing 12 of 110. All 110 manufacturers in China registered for Instrument, Manual, Surgical, General Use
Record
| Listed by | Nvision Biomedical Technologies, Inc, United States |
|---|---|
| FDA product code | MDM |
| Device type | Instrument, Manual, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-22 |
| Record revised | 2026-07-28 (version 5) |
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 |
| Storage | Special storage condition: A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PD-1000T-113 | In distribution | |
| PD-1000T-043 | In distribution | |
| PD-1000T-067 | In distribution | |
| PD-1000T-045 | In distribution | |
| PD-1000T-098 | In distribution | |
| PD-1000T-074 | In distribution | |
| PD-1000T-103 | In distribution | |
| PD-1000T-003 | In distribution | |
| PD-1000T-015 | In distribution | |
| PD-1000T-064 | In distribution | |
| PD-1000T-022 | In distribution | |
| PD-1000T-018 | In distribution | |
| PD-1000T-055 | In distribution | |
| PD-1000T-063 | In distribution | |
| PD-1000T-101 | In distribution | |
| PD-1000T-042 | In distribution | |
| PD-1000T-009 | In distribution | |
| PD-1000T-052 | In distribution | |
| PD-1000T-014 | In distribution | |
| PD-1000T-023 | In distribution | |
| PD-1000T-112 | In distribution | |
| PD-1000T-027 | In distribution | |
| PD-1000T-005 | In distribution | |
| PD-1000T-095 | In distribution | |
| PD-1000T-062 | In distribution | |
| PD-1000T-007 | In distribution | |
| PD-1000T-001 | In distribution | |
| PD-1000T-105 | In distribution | |
| PD-1000T-060 | In distribution | |
| PD-1000T-024 | In distribution | |
| PD-1000T-065 | In distribution | |
| PD-1000T-006 | In distribution | |
| PD-1000T-096 | In distribution | |
| PD-1000T-041 | In distribution | |
| PD-1000T-002 | In distribution | |
| PD-1000T-108 | In distribution | |
| PD-1000T-061 | In distribution | |
| PD-1000T-068 | In distribution | |
| PD-1000T-111 | In distribution | |
| PD-1000T-008 | In distribution | |
| PD-1000T-102 | In distribution | |
| PD-1000T-025 | In distribution | |
| PD-1000T-054 | In distribution | |
| PD-1000T-053 | In distribution | |
| PD-1000T-066 | In distribution | |
| PD-1000T-040 | In distribution | |
| PD-1000T-110 | In distribution | |
| PD-1000T-059 | In distribution | |
| PD-1000T-016 | In distribution | |
| PD-1000T-026 | In distribution | |
| PD-1000T-017 | In distribution | |
| PD-1000T-109 | In distribution | |
| PD-1000T-107 | In distribution | |
| PD-1000T-100 | In distribution | |
| PD-1000T-051 | In distribution | |
| PD-1000T-097 | In distribution | |
| PD-1000T-099 | In distribution | |
| PD-1000T-073 | In distribution | |
| PD-1000T-044 | In distribution | |
| PD-1000T-050 | In distribution | |
| PD-1000T-004 | In distribution | |
| PD-1000T-020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 1,686 |
| TSI | Tedan Surgical Innovations, L.L.C. | 1,181 |
| Medfix | Medfix International, LLC | 514 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 446 |
| Fentex | Fentex medical GmbH | 407 |
| Millennium | Avalign Technologies, Inc. | 337 |
| Synergetics | Synergetics USA, Inc. | 312 |
| American Medicals | American Medicals | 298 |
| gSource | Gsource, LLC. | 291 |
| Life Instruments | Life Instrument Corp. | 274 |
| Ambler Surgical | Ambler Surgical, LLC | 272 |
| Instrument, Manual, Surgical, General Use | Karl Storz GmbH & Co. KG | 261 |
Showing 12 of 1,364. All products under Instrument, Manual, Surgical, General Use
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.