Retractor
134 catalogue numbers from 3081-02, listed by Zimmer, Inc., United States, under Retractor. 34 manufacturers in China are registered for this product code.
34manufacturers in China registered for this device type
134catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (7), Zhejiang (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Showing 12 of 34. All 34 manufacturers in China registered for Retractor
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-07-27 |
| Record revised | 2024-09-11 (version 6) |
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, manufacturing date, serial number |
| Sizes | Width 6 to 15 mm |
| Distribution end date | 2017-06-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3081-02 | In distribution | |
| SSI005323 | Left Short | In distribution |
| 00-7807-001-01 | In distribution | |
| 332 | 9/16 Inch Width 11/16 Inch Ins. Rad. | In distribution |
| 75.43.01 | In distribution | |
| 232 | In distribution | |
| 75.18.02 | In distribution | |
| 3027 | In distribution | |
| 7804-11-01 | In distribution | |
| 75.26.05 | In distribution | |
| 233-03 | Blade Depth 2-3/4 Inch (7 cm) | In distribution |
| 7806-05-30 | In distribution | |
| 5983-82 | In distribution | |
| 3088-02 | In distribution | |
| 449 | 3.2 cm Blade Width, 10.2 cm Blade Depth | In distribution |
| 00-7807-007-03 | In distribution | |
| 00-7807-007-01 | In distribution | |
| 3088-01 | In distribution | |
| 7804-07 | In distribution | |
| SSI005322 | Right Short | In distribution |
| 76.15.11 | In distribution | |
| 3053 | 25 mm Blade Width, 33 mm Blade Depth | In distribution |
| 3075 | Length 9 1/4 Inch (235 mm) | In distribution |
| 3088-20 | Width 6 mm | In distribution |
| 248 | In distribution | |
| 5983-81 | In distribution | |
| 7804-01-05 | In distribution | |
| 484-02 | 6-1/4 Inch (159 mm) Length | In distribution |
| 00-7807-006-02 | In distribution | |
| 7804-01-02 | In distribution | |
| 75.24.03 | In distribution | |
| 233-06 | Blade Depth 4-1/2 Inch (11 cm) | In distribution |
| 4033-27 | In distribution | |
| 549-01 | 4.4 cm Blade Width | In distribution |
| 484-01 | 5-1/4 Inch (133 mm) Length | In distribution |
| 3008 | In distribution | |
| 549-02 | 6.4 cm Blade Width | In distribution |
| 7804-11-02 | In distribution | |
| 448 | 3.2 cm Blade Width, 7.6 cm Blade Depth | In distribution |
| 7806-05-20 | In distribution | |
| 9375-00-011 | In distribution | |
| 9027-15 | In distribution | |
| 00-7807-004-01 | In distribution | |
| 330 | 9/32 Inch Width 1-5/8 Inch Ins. Rad. | In distribution |
| 7804-12-02 | In distribution | |
| 5983-83 | In distribution | |
| 233-05 | Blade Depth 4 Inch (10 cm) | In distribution |
| 3088-21 | Width 8 mm | In distribution |
| 233-01 | Blade Depth 1-3/4 Inch (4.5 cm) | In distribution |
| 00-7807-004-02 | In distribution | |
| 233-02 | Blade Depth 2-1/4 Inch (5.7 cm) | In distribution |
| 7806-05-40 | In distribution | |
| 4033-45-01 | In distribution | |
| 3088-22 | Width 15 mm | In distribution |
| 5983-84 | In distribution | |
| 75.08.00 | In distribution | |
| 7804-08 | In distribution | |
| 3006 | In distribution | |
| 00-7806-005-51 | In distribution | |
| 00-2366-060-20 | In distribution | |
| 331 | 9/32 Inch Width 11/16 Inch Ins. Rad. | In distribution |
| 4033-46-01 | In distribution | |
| 2037 | In distribution | |
| 4033-23 | In distribution | |
| 3081-01 | In distribution | |
| 00-7807-005-01 | In distribution | |
| 4033-02-01 | In distribution | |
| 3010-04 | 4 Prong | In distribution |
| 75.22.07 | In distribution | |
| 00-2366-070-00 | In distribution | |
| 5983-80-01 | In distribution | |
| 75.22.06 | In distribution | |
| 00-7807-002-01 | In distribution | |
| 3088-03 | In distribution | |
| 1154-40 | In distribution | |
| 3081-03 | In distribution | |
| SSI005320 | Right Long | In distribution |
| 7804-01-06 | In distribution | |
| 00-7807-006-01 | In distribution | |
| 7804-06 | In distribution | |
| 7804-01-01 | In distribution | |
| 7804-05 | In distribution | |
| 00-7807-006-03 | In distribution | |
| 00-7806-005-52 | In distribution | |
| 00-7807-008-01 | In distribution | |
| 7804-09 | In distribution | |
| SSI005321 | Left Long | In distribution |
| 75.40.08 | In distribution | |
| 7806-05-10 | In distribution | |
| 00-2366-060-10 | In distribution | |
| 4033-43-01 | In distribution | |
| 7804-03-01 | In distribution | |
| 2973 | In distribution | |
| 3045-03 | Length 9-1/2 Inch (24.1 cm) | In distribution |
| 7804-03-03 | In distribution | |
| 7804-03-02 | In distribution | |
| 4033-44-01 | In distribution | |
| 00-7807-003-01 | In distribution | |
| 5061-83 | 7 Inch (17.8 cm) | In distribution |
| 233-04 | Blade Depth 3-1/4 Inch (8.3 cm) | In distribution |
| 7804-12-01 | In distribution | |
| 3045-01 | 6-1/2 Inch (16.5 cm) | Withdrawn |
| 9375-00-043 | Withdrawn | |
| 9375-00-044 | Withdrawn | |
| 3066-04 | 19.1 mm Blade Width, 60.3 mm Blade Length | Withdrawn |
| 7804-10-04 | Withdrawn | |
| 9375-00-049 | Withdrawn | |
| 5983-80-03 | Withdrawn | |
| 9375-00-047 | Withdrawn | |
| 3010-06 | 6 Prong | Withdrawn |
| 2967-03 | 3 Prong | Withdrawn |
| 3011-04 | 4 Prong | Withdrawn |
| 3010-02 | 2 Prong | Withdrawn |
| 3066-05 | Withdrawn | |
| 3045-02 | 8 Inch (20.3 cm) | Withdrawn |
| 3020 | Length 7-1/2 Inch (191 mm) | Withdrawn |
| 9375-00-046 | Withdrawn | |
| 2968-03 | 3 Prong | Withdrawn |
| 7804-10-03 | Withdrawn | |
| 9027-16 | Withdrawn | |
| 233-07 | Withdrawn | |
| 3066-01 | 12.7 mm Blade Width, 57.2 mm Blade Length | Withdrawn |
| 3066-02 | 19.1 mm Blade Width, 34.9 mm Blade Length | Withdrawn |
| 249 | Withdrawn | |
| 2967-02 | 2 Prong | Withdrawn |
| 3066-03 | 19.1 mm Blade Width, 50.8 mm Blade Length | Withdrawn |
| 3019 | Withdrawn | |
| 3025 | 4 Prong | Withdrawn |
| 9375-00-045 | Withdrawn | |
| 3011-06 | 6 Prong | Withdrawn |
| 5983-80-02 | Withdrawn | |
| 9027-17 | Withdrawn | |
| 3005 | Withdrawn | |
| 9375-00-048 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thompson | Thompson Surgical Instruments, Inc. | 4,354 |
| Millennium | Avalign Technologies, Inc. | 2,128 |
| Surtex | Surtex Instruments Ltd | 1,318 |
| Life Instruments | Life Instrument Corp. | 1,135 |
| Innomed, Inc. | Innomed, Inc. | 1,017 |
| Aesculap | Aesculap AG | 1,013 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 973 |
| Elmed | Elmed, Inc. | 919 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 891 |
| Boss Instruments | Boss Instruments, Ltd. | 799 |
| gSource | Gsource, LLC. | 753 |
| Sklar® | Sklar Corporation | 753 |
Showing 12 of 2,238. All products under Retractor
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K830287 | 1983-03-09 |
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.