Pectus Versa System
105 catalogue numbers from EXTERNAL PECTUS BAR - STRAIGHT 220.0mm, listed by GM DOS Reis Industria E Comercio Ltda, Brazil, under Plate, Fixation, Bone. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
105catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | GM DOS Reis Industria E Comercio Ltda, Brazil |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2025-12-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EXTERNAL PECTUS BAR – STRAIGHT 220.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 180.0mm | In distribution | |
| PECTUS BAR – ANGLED 250.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 260.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 320.0mm | In distribution | |
| PECTUS BAR – ANGLED 290.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 330.0mm | In distribution | |
| PECTUS BAR – ANGLED 400.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 250.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 260.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 330.0mm | In distribution | |
| ANGLED STABILIZER 10-R | In distribution | |
| CONNECTOR BAR – 120.0mm | In distribution | |
| NEUTRAL LONG STABILIZER | In distribution | |
| PECTUS BAR – ANGLED 350.0mm | In distribution | |
| CONNECTOR BAR – 70.0mm | In distribution | |
| PECTUS BAR – ANGLED 330.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 280.0mm | In distribution | |
| PECTUS BAR – ANGLED 260.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 360.0mm | In distribution | |
| PECTUS BAR – ANGLED 210.0mm | In distribution | |
| CONNECTOR BAR – 30.0mm | In distribution | |
| PECTUS BAR – ANGLED 310.0mm | In distribution | |
| ANGLED LONG STABILIZER 10-L | In distribution | |
| PECTUS BAR – ANGLED 380.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 250.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 230.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 190.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 350.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 350.0mm | In distribution | |
| ANGLED STABILIZER 20-R | In distribution | |
| EXTERNAL LOCKING SCREW | In distribution | |
| PECTUS BAR – STRAIGHT 320.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 410.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 230.0mm | In distribution | |
| ANGLED OFFSET STABILIZER 10-L | In distribution | |
| NEUTRAL OFFSET STABILIZER | In distribution | |
| PECTUS BAR – STRAIGHT 390.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 370.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 270.0mm | In distribution | |
| 371-02-190 | In distribution | |
| PECTUS BAR – ANGLED 360.0mm | In distribution | |
| CONNECTOR BAR – 130.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 360.0mm | In distribution | |
| NEUTRAL STABILIZER | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 340.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 310.0mm | In distribution | |
| PECTUS BAR – ANGLED 230.0mm | In distribution | |
| PECTUS BAR – ANGLED 420.0mm | In distribution | |
| PECTUS BAR – ANGLED 320.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 310.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 290.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 410.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 200.0mm | In distribution | |
| PECTUS BAR – ANGLED 270.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 240.0mm | In distribution | |
| PECTUS BAR – ANGLED 220.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 180.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 400.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 210.0mm | In distribution | |
| CONNECTOR BAR – 150.0mm | In distribution | |
| CONNECTOR BAR – 140.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 300.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 220.0mm | In distribution | |
| PECTUS BAR – ANGLED 410.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 380.0mm | In distribution | |
| LOCKING SCREW | In distribution | |
| ANGLED OFFSET STABILIZER 20-R | In distribution | |
| PECTUS BAR – STRAIGHT 270.0mm | In distribution | |
| CONNECTOR BAR – 50.0mm | In distribution | |
| CONNECTOR BAR – 100.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 370.0mm | In distribution | |
| PECTUS BAR – ANGLED 200.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 290.0mm | In distribution | |
| PECTUS BAR – ANGLED 390.0mm | In distribution | |
| ANGLED STABILIZER 20-L | In distribution | |
| ANGLED LONG STABILIZER 20-L | In distribution | |
| ANGLED LONG STABILIZER 20-R | In distribution | |
| PECTUS BAR – STRAIGHT 340.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 420.0mm | In distribution | |
| ANGLED OFFSET STABILIZER 10-R | In distribution | |
| PECTUS BAR – STRAIGHT 300.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 420.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 200.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 400.0mm | In distribution | |
| PECTUS BAR – ANGLED 340.0mm | In distribution | |
| PECTUS BAR – ANGLED 280.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 210.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 380.0mm | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 240.0mm | In distribution | |
| PECTUS BAR – ANGLED 240.0mm | In distribution | |
| CONNECTOR BAR – 110.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 190.0mm | In distribution | |
| ANGLED STABILIZER 10-L | In distribution | |
| EXTERNAL PECTUS BAR – STRAIGHT 390.0mm | In distribution | |
| PECTUS BAR – ANGLED 370.0mm | In distribution | |
| ANGLED OFFSET STABILIZER 20-L | In distribution | |
| CONNECTOR BAR – 40.0mm | In distribution | |
| PECTUS BAR – ANGLED 300.0mm | In distribution | |
| PECTUS BAR – STRAIGHT 280.0mm | In distribution | |
| ANGLED LONG STABILIZER 10-R | In distribution | |
| PECTUS BAR – ANGLED 180.0mm | In distribution | |
| CONNECTOR BAR – 60.0mm | In distribution | |
| CONNECTOR BAR – 80.0mm | In distribution | |
| CONNECTOR BAR – 90.0mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262537 | 2026-08-19 |
| K261406 | 2026-07-21 |
| K260390 | 2026-03-17 |
| K243740 | 2025-01-29 |
| K242998 | 2024-11-21 |
| K242596 | 2024-11-21 |
| K232829 | 2024-06-26 |
| K231684 | 2024-01-12 |
| K201728 | 2021-03-08 |
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.