Otelo Instrumentation
Anterior Blade - Down - 10MM - Short Shank
34manufacturers in China registered for this device type
232catalogue 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 | Spineart SA, Switzerland |
|---|---|
| FDA product code | GAD |
| Device type | Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-16 |
| Record revised | 2025-03-31 (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 |
| Sizes | Height 40 to 130 mm; length 100 to 150 mm; outer diameter 18 mm; width 12 to 18 mm |
| Distribution end date | 2019-02-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RTR-IN 00 12-N | In distribution | |
| RTR-IN 00 18-N | In distribution | |
| RTR-IN 00 22-N | In distribution | |
| OTO-IN L1 50-N | In distribution | |
| OTO-IN 05 01-N | In distribution | |
| OTO-IN L1 10-N | In distribution | |
| OTO-IN R1 10-N | In distribution | |
| RTR-IN 02 10-N | In distribution | |
| OTO-IN 06 00-N | In distribution | |
| OTO-IN CR 00-N | In distribution | |
| MIS-IN 44 50-N | In distribution | |
| OTO-BC 10 01-N | Height 100 mm | In distribution |
| RTR-IN 01 20-N | In distribution | |
| SPE-US L1 30-N | Outer Diameter 18 mm | In distribution |
| OTO-IN R1 50-N | In distribution | |
| RTR-IN 00 90-N | In distribution | |
| RTR-IN 01 30-N | In distribution | |
| RTR-IN 00 16-Nv | In distribution | |
| RTR-IN 00 15-N | In distribution | |
| SPE-US R1 40-N | Outer Diameter 18 mm | In distribution |
| SPE-US L1 50-N | Outer Diameter 18 mm | In distribution |
| OTO-IN R1 40-N | In distribution | |
| OTO-IN 07 01-N | In distribution | |
| OTO-BT 06 03-N | Height 60 mm | In distribution |
| OTO-IN AB 00-N | In distribution | |
| OTO-IN 02 00-N | In distribution | |
| SPE-US 00 23-N | Width 12 mm | In distribution |
| OTO-IN P1 20-N | In distribution | |
| RTR-IN 02 00-N | In distribution | |
| OTO-BC 12 02-N | Height 120 mm | In distribution |
| OTO-BC 06 02-N | Height 60 mm | In distribution |
| OTO-BA 08 04-N | Height 80 mm | In distribution |
| OTO-IN L1 30-N | In distribution | |
| OTO-IN AB 04-N | In distribution | |
| RTR-IN 01 00-N | In distribution | |
| OTO-BC 05 03-N | Height 50 mm | In distribution |
| SPE-US L1 10-N | Outer Diameter 18 mm | In distribution |
| OTO-IN 31 01-N | In distribution | |
| OTO-IN 36 00-N | In distribution | |
| SPE-US P1 30-N | Outer Diameter 18 mm | In distribution |
| RTR-IN 01 80-N | In distribution | |
| OTO-IN 4B 00-N | In distribution | |
| SPE-US 00 24-N | Length 130 mm | In distribution |
| RTR-IN 00 02-N | In distribution | |
| OTO-BT 07 03-N | Height 70 mm | In distribution |
| OTO-IN 05 00-S | In distribution | |
| OTO-IN AB 06-N | In distribution | |
| MIS-IN 44 20-N | In distribution | |
| MIS-IN 44 40-N | In distribution | |
| OTO-IN L1 40-N | In distribution | |
| RTR-IN 00 70-N | In distribution | |
| OTO-BA 04 04-N | Height 40 mm | In distribution |
| OTO-BC 10 02-N | Height 100 mm | In distribution |
| RTR-IN 00 06-N | In distribution | |
| OTO-IN R1 20-N | In distribution | |
| OTO-BA 12 04-N | Height 120 mm | In distribution |
| OTO-IN 34 00-N | In distribution | |
| OTO-BC 04 03-N | Height 40 mm | In distribution |
| OTO-IN R1 60-N | In distribution | |
| RTR-IN 00 17-N | In distribution | |
| OTO-BC 12 03-N | Length 120 mm | In distribution |
| SPE-US 00 22-N | In distribution | |
| RTR-IN 00 20-N | In distribution | |
| SPE-US L1 20-N | Length 120 mm | In distribution |
| OTO-BC 08 02-N | Height 80 mm | In distribution |
| OTO-BA 09 04-N | Height 90 mm | In distribution |
| OTO-IN P1 50-N | In distribution | |
| OTO-BC 09 03-N | Height 90 mm | In distribution |
| RTR-IN 00 04-N | In distribution | |
| SPE-US P1 50-N | Outer Diameter 18 mm | In distribution |
| OTO-IN 05 06-N | In distribution | |
| OTO-IN P1 30-N | In distribution | |
| RTR-IN 00 03-N | In distribution | |
| OTO-BA 05 04-N | Height 50 mm | In distribution |
| SPE-US R1 10-N | Outer Diameter 18 mm | In distribution |
| OTO-BA 07 04-N | Height 70 mm | In distribution |
| OTO-BC 04 01-N | Height 40 mm | In distribution |
| RTR-IN 00 08-N | In distribution | |
| OTO-BT 09 03-N | Height 90 mm | In distribution |
| OTO-IN L1 60-N | In distribution | |
| OTO-IN AB 07-N | In distribution | |
| OTO-IN R1 00-N | In distribution | |
| OTO-BA 13 04-N | Height 130 mm | In distribution |
| RTR-IN 00 10-N | In distribution | |
| OTO-IN R0 90-N | In distribution | |
| RTR-IN 00 14-N | In distribution | |
| SPE-US P1 40-N | Length 140 mm | In distribution |
| OTO-IN 01 04-N | In distribution | |
| SPE-US R1 00-N | Length 100 mm | In distribution |
| OTO-IN AB 03-N | In distribution | |
| OTO-BC 05 01-N | Height 50 mm | In distribution |
| OTO-IN P1 70-N | In distribution | |
| OTO-IN AB 02-N | In distribution | |
| OTO-BC 05 02-N | Height 50 mm | In distribution |
| OTO-IN 08 00-N | In distribution | |
| RTR-IN 01 50-N | In distribution | |
| SPE-US 00 10-N | In distribution | |
| OTO-IN 05 02-N | In distribution | |
| RTR-IN 00 50-N | In distribution | |
| OTO-IN L1 20-N | In distribution | |
| RTR-IN 00 05-N | In distribution | |
| OTO-IN P1 00-N | In distribution | |
| RTR-IN 00 01-N | In distribution | |
| OTO-IN 06 01-N | In distribution | |
| OTO-IN 32 01-N | In distribution | |
| OTO-IN 01 00-N | In distribution | |
| RTR-IN 01 70-N | In distribution | |
| OTO-IN R1 30-N | In distribution | |
| OTO-IN 07 02-N | In distribution | |
| SPE-US P1 10-N | Outer Diameter 18 mm | In distribution |
| OTO-BC 11 03-N | Height 110 mm | In distribution |
| RTR-IN 00 80-N | In distribution | |
| OTO-BC 12 01-N | Height 120 mm | In distribution |
| OTO-IN L1 70-N | In distribution | |
| OTO-IN 30 01-N | In distribution | |
| OTO-IN P0 90-N | In distribution | |
| RTR-IN 00 13-N | In distribution | |
| SPE-US R1 50-N | Length 150 mm | In distribution |
| OTO-BC 13 01-N | Height 130 mm | In distribution |
| OTO-BA 10 04-N | Height 100 mm | In distribution |
| SPE-US R1 30-N | Outer Diameter 18 mm | In distribution |
| OTO-IN 37 00-N | In distribution | |
| OTO-BC 08 01-N | Height 80 mm | In distribution |
| RTR-IN 00 00-N | In distribution | |
| OTO-BC 04 02-N | Height 40 mm | In distribution |
| OTO-IN 05 05-N | In distribution | |
| SPE-US P1 00-N | Length 100 mm | In distribution |
| OTO-IN 04 00-N | In distribution | |
| OTO-BC 11 02-N | Height 110 mm | In distribution |
| OTO-IN 01 01-N | In distribution | |
| RTR-IN 01 10-N | In distribution | |
| OTO-BC 09 02-N | Height 90 mm | In distribution |
| OTO-BC 10 03-N | Height 100 mm | In distribution |
| OTO-BT 08 03-N | Height 80 mm | In distribution |
| RTR-IN 00 07-N | In distribution | |
| OTO-IN R1 80-N | In distribution | |
| OTO-IN L1 80-N | In distribution | |
| OTO-IN 31 01-S | In distribution | |
| SPE-US 01 01-N | In distribution | |
| OTO-IN L0 90-N | In distribution | |
| MIS-IN 44 30-N | In distribution | |
| OTO-IN P1 60-N | In distribution | |
| OTO-BC 07 02-N | Height 70 mm | In distribution |
| OTO-BT 05 03-N | Height 50 mm | In distribution |
| OTO-IN 05 03-S | In distribution | |
| SPE-US 00 21-N | In distribution | |
| OTO-BC 07 01-N | Height 70 mm | In distribution |
| OTO-IN 01 02-N | In distribution | |
| OTO-BC 06 03-N | Height 60 mm | In distribution |
| SPE-US L1 40-N | Length 140 mm | In distribution |
| OTO-BC 06 01-N | Height 60 mm | In distribution |
| RTR-IN 01 90-N | In distribution | |
| OTO-IN 05 03-N | In distribution | |
| OTO-IN 03 00-N | In distribution | |
| OTO-BC 11 01-N | Height 110 mm | In distribution |
| RTR-IN 00 09-N | In distribution | |
| OTO-IN 33 00-N | In distribution | |
| OTO-BA 06 04-N | Height 60 mm | In distribution |
| SPE-US R1 20-N | Length 120 mm | In distribution |
| RTR-IN 01 40-N | In distribution | |
| OTO-IN AB 05-N | In distribution | |
| OTO-BC 09 01-N | Height 90 mm | In distribution |
| OTO-IN P1 10-N | In distribution | |
| OTO-IN R1 70-N | In distribution | |
| OTO-BC 13 03-N | Length 130 mm | In distribution |
| SPE-US P1 20-N | Length 120 mm | In distribution |
| OTO-IN 05 00-N | In distribution | |
| OTO-IN P1 40-N | In distribution | |
| RTR-IN 00 19-N | In distribution | |
| OTO-IN AB 01-N | In distribution | |
| OTO-BA 11 04-N | Height 110 mm | In distribution |
| OTO-IN L1 00-N | In distribution | |
| RTR-IN 00 11-N | In distribution | |
| RTR-IN 01 60-N | In distribution | |
| OTO-BC 13 02-N | Height 130 mm | In distribution |
| SPE-US 00 30-N | In distribution | |
| SPE-US L1 00-N | Length 100 mm | In distribution |
| RTR-IN 00 60-N | In distribution | |
| OTO-IN P1 80-N | In distribution | |
| RTR-IN 00 21-N | In distribution | |
| OTO-BC 08 03-N | Height 80 mm | In distribution |
| OTO-BC 07 03-N | Height 70 mm | In distribution |
| OTO-IN CR 01-N | In distribution | |
| OTO-IN 33 00-N | Withdrawn | |
| OTO-IN L1 80-N | Withdrawn | |
| OTO-IN L1 40-N | Withdrawn | |
| OTO-IN R1 40-N | Withdrawn | |
| OTO-IN P1 30-N | Withdrawn | |
| OTO-IN 05 05-N | Withdrawn | |
| OTO-IN L1 50-N | Withdrawn | |
| OTO-IN 31 01-N | Withdrawn | |
| OTO-IN R1 80-N | Withdrawn | |
| OTO-IN L0 90-N | Withdrawn | |
| OTO-IN R1 20-N | Withdrawn | |
| OTO-IN L1 10-N | Withdrawn | |
| OTO-IN 08 00-N | Withdrawn | |
| OTO-IN R1 00-N | Withdrawn | |
| OTO-IN P1 10-N | Withdrawn | |
| OTO-IN L1 60-N | Withdrawn | |
| OTO-IN AB 03-N | Withdrawn | |
| OTO-IN 05 00-N | Withdrawn | |
| OTO-IN 32 01-N | Withdrawn | |
| OTO-IN 05 03-N | Withdrawn | |
| OTO-IN 06 00-N | Withdrawn | |
| OTO-IN CR 00-N | Withdrawn | |
| OTO-IN R1 70-N | Withdrawn | |
| OTO-IN AB 02-N | Withdrawn | |
| OTO-IN P1 60-N | Withdrawn | |
| OTO-IN R1 50-N | Withdrawn | |
| OTO-IN AB 00-N | Withdrawn | |
| OTO-IN R1 60-N | Withdrawn | |
| OTO-IN R1 30-N | Withdrawn | |
| OTO-IN 34 00-N | Withdrawn | |
| OTO-IN P1 00-N | Withdrawn | |
| OTO-IN 30 01-N | Withdrawn | |
| OTO-IN AB 01-N | Withdrawn | |
| OTO-IN P1 80-N | Withdrawn | |
| OTO-IN 36 00-N | Withdrawn | |
| OTO-IN R1 10-N | Withdrawn | |
| OTO-IN 4B 00-N | Withdrawn | |
| OTO-IN P1 20-N | Withdrawn | |
| OTO-IN L1 70-N | Withdrawn | |
| OTO-IN 05 06-N | Withdrawn | |
| OTO-IN P1 70-N | Withdrawn | |
| OTO-IN L1 00-N | Withdrawn | |
| OTO-IN L1 20-N | Withdrawn | |
| OTO-IN CR 01-N | Withdrawn | |
| OTO-IN L1 30-N | Withdrawn | |
| OTO-IN P1 50-N | Withdrawn | |
| OTO-IN P0 90-N | Withdrawn | |
| OTO-IN R0 90-N | Withdrawn | |
| OTO-IN P1 40-N | 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 |
|---|---|
| K151104 | 2016-01-06 |
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.