Loqteq®
LOQTEQ VA Elbow Plates 2.7/3.5 are bone plates and screws for internal fixation of bone fragments, typically following fractures or other bone injuries. The filing describes plates for the…
LOQTEQ VA Elbow Plates 2.7/3.5 are bone plates and screws for internal fixation of bone fragments, typically following fractures or other bone injuries. The filing describes plates for the distal humerus and olecranon, shaped for local anatomy and biomechanical loading.
The plate-screw connection is angularly stable: threaded screw heads engage threaded plate holes. Conventional screws can also be used in the holes, with off-axis angulation up to 15 degrees. After fracture healing, the filing says the plates and screws are to be removed.
Listed Item
LOQTEQ® VA Distal Dorsolateral Humerus Plate, 11 holes, L 206, R, Titanium
Plate Configuration
The system includes distal humerus and olecranon plates. Its intended use covers fixation of fractures, osteotomies and nonunions in the specified elbow bones. The filing identifies the device as LOQTEQ VA Elbow Plates 2.7/3.5 and describes the included plates as trauma implants.
22manufacturers in China registered for this device type
353catalogue numbers in this listing
25510(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 | AAP Implantate AG, Germany |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K230141 |
| Record published | 2016-08-18 |
| Record revised | 2025-11-20 (version 8) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PK 3541-08-2 | In distribution | |
| PH 3533-07-2 | In distribution | |
| PF 2523-06-2 | In distribution | |
| PG 3555-10-2 | In distribution | |
| PO 4562-01-2 | In distribution | |
| PH 3532-03-2 | In distribution | |
| PH 3541-05-2 | In distribution | |
| PG 3553-03-2 | In distribution | |
| PA 3532-14-2 | In distribution | |
| PH 3523-03-2 | In distribution | |
| PF 2532-06-2 | In distribution | |
| PF 4511-15-2 | In distribution | |
| PG 4556-24-2 | In distribution | |
| PF 2524-06-2 | In distribution | |
| PG 3555-07-2 | In distribution | |
| PK 3522-06-2 | In distribution | |
| PA 3551-06-2 | In distribution | |
| PG 4556-08-2 | In distribution | |
| PK 3541-10-2 | In distribution | |
| PH 3524-11-2 | In distribution | |
| PA 4531-10-2 | In distribution | |
| PR 3550-18-2 | In distribution | |
| PH 3543-03-2 | In distribution | |
| PA 3533-03-2 | In distribution | |
| PR 2512-05-2 | In distribution | |
| PA 3534-03-2 | In distribution | |
| PA 3532-04-2 | In distribution | |
| PR 2545-08-2 | In distribution | |
| PK 3521-10-2 | In distribution | |
| PA 3522-06-2 | In distribution | |
| PG 3553-04-2 | In distribution | |
| PG 4556-16-2 | In distribution | |
| PF 2522-06-2 | In distribution | |
| PA 3534-10-2 | In distribution | |
| PG 3555-18-2 | In distribution | |
| PA 3561-03-2 | In distribution | |
| PF 4511-13-2 | In distribution | |
| PF 2540-06-2 | In distribution | |
| PR 3550-05-2 | In distribution | |
| PH 3544-07-2 | In distribution | |
| PR 2522-03-2 | In distribution | |
| PG 3555-12-2 | In distribution | |
| PG 4555-14-2 | In distribution | |
| PA 3562-03-2 | In distribution | |
| PA 4531-08-2 | In distribution | |
| PA 3532-08-2 | In distribution | |
| PG 4555-06-2 | In distribution | |
| PK 3511-07-2 | In distribution | |
| PA 3531-03-2 | In distribution | |
| PR 3550-20-2 | In distribution | |
| PG 4556-09-2 | In distribution | |
| PR 3550-07-2 | In distribution | |
| PK 3521-06-2 | In distribution | |
| PH 3541-02-2 | In distribution | |
| PH 3542-03-2 | In distribution | |
| PA 3541-17-2 | In distribution | |
| PG 4555-04-2 | In distribution | |
| PH 3541-03-2 | In distribution | |
| PA 3561-10-2 | In distribution | |
| PG 3553-07-2 | In distribution | |
| PH 3523-05-2 | In distribution | |
| PK 3512-07-2 | In distribution | |
| PF 4511-07-2 | In distribution | |
| PA 3521-04-2 | In distribution | |
| PF 2511-04-2 | In distribution | |
| PH 3510-12-2 | In distribution | |
| PO 4560-01-2 | In distribution | |
| PH 3510-06-2 | In distribution | |
| PF 2540-08-2 | In distribution | |
| PF 3514-70-2 | In distribution | |
| PG 4556-07-2 | In distribution | |
| PA 4532-08-2 | In distribution | |
| PF 2545-07-2 | In distribution | |
| PA 3522-04-2 | In distribution | |
| PK 3542-08-2 | In distribution | |
| PA 3532-03-2 | In distribution | |
| PK 3512-05-2 | In distribution | |
| PK 3532-07-2 | In distribution | |
| PF 2541-05-2 | In distribution | |
| PH 3523-11-2 | In distribution | |
| PH 3531-05-2 | In distribution | |
| PH 3531-03-2 | In distribution | |
| PU 3532-04-2 | In distribution | |
| PR 2512-11-2 | In distribution | |
| PR 2521-03-2 | In distribution | |
| PR 2541-06-2 | In distribution | |
| PH 3532-05-2 | In distribution | |
| PA 4531-14-2 | In distribution | |
| PK 3531-07-2 | In distribution | |
| PA 3531-14-2 | In distribution | |
| PG 3555-08-2 | In distribution | |
| PA 3552-03-2 | In distribution | |
| PA 3564-04-2 | In distribution | |
| PG 4556-20-2 | In distribution | |
| PH 3531-02-2 | In distribution | |
| PF 2541-06-2 | In distribution | |
| PU 3533-10-2 | In distribution | |
| PG 4555-11-2 | In distribution | |
| PA 3542-09-2 | In distribution | |
| PU 3531-10-2 | In distribution | |
| PH 3523-02-2 | In distribution | |
| PA 3534-14-2 | In distribution | |
| PF 2525-09-2 | In distribution | |
| PH 3542-02-2 | In distribution | |
| PF 2544-02-2 | In distribution | |
| PH 3510-10-2 | In distribution | |
| PH 3544-02-2 | In distribution | |
| PH 3543-11-2 | In distribution | |
| PH 3524-02-2 | In distribution | |
| PA 4531-06-2 | In distribution | |
| PR 3550-06-2 | In distribution | |
| PA 3523-10-2 | In distribution | |
| PA 3563-10-2 | In distribution | |
| PG 4556-22-2 | In distribution | |
| PF 4510-11-2 | In distribution | |
| PF 3511-60-2 | In distribution | |
| PH 3521-02-2 | In distribution | |
| PR 2511-11-2 | In distribution | |
| PG 3553-05-2 | In distribution | |
| PR 3550-14-2 | In distribution | |
| PK 3521-08-2 | In distribution | |
| PA 3552-10-2 | In distribution | |
| PA 3522-12-2 | In distribution | |
| PG 3553-12-2 | In distribution | |
| PF 2515-04-2 | In distribution | |
| PH 3522-11-2 | In distribution | |
| PG 3553-09-2 | In distribution | |
| PR 3550-16-2 | In distribution | |
| PF 3514-60-2 | In distribution | |
| PA 4532-05-2 | In distribution | |
| PA 3541-05-2 | In distribution | |
| PG 4555-07-2 | In distribution | |
| PF 3513-70-2 | In distribution | |
| PH 3542-07-2 | In distribution | |
| PO 4561-01-2 | In distribution | |
| PG 4556-11-2 | In distribution | |
| PA 3542-07-2 | In distribution | |
| PU 3532-10-2 | In distribution | |
| PF 4510-15-2 | In distribution | |
| PA 3534-06-2 | In distribution | |
| PA 3563-08-2 | In distribution | |
| PA 3531-08-2 | In distribution | |
| PR 3550-08-2 | In distribution | |
| PH 3534-03-2 | In distribution | |
| PF 2526-09-2 | In distribution | |
| PH 3521-05-2 | In distribution | |
| PA 3532-12-2 | In distribution | |
| PA 3542-12-2 | In distribution | |
| PA 3561-08-2 | In distribution | |
| PU 3531-08-2 | In distribution | |
| PG 3555-06-2 | In distribution | |
| PA 3551-10-2 | In distribution | |
| PU 3534-08-2 | In distribution | |
| PA 3521-12-2 | In distribution | |
| PA 3523-12-2 | In distribution | |
| PF 2513-05-2 | In distribution | |
| PG 3555-09-2 | In distribution | |
| PG 4555-20-2 | In distribution | |
| PA 4531-12-2 | In distribution | |
| PG 4555-05-2 | In distribution | |
| PA 3524-04-2 | In distribution | |
| PU 3533-06-2 | In distribution | |
| PA 3524-12-2 | In distribution | |
| PH 3521-11-2 | In distribution | |
| PR 2511-03-2 | In distribution | |
| PH 3531-11-2 | In distribution | |
| PA 3522-16-2 | In distribution | |
| PA 3534-04-2 | In distribution | |
| PF 4511-11-2 | In distribution | |
| PR 3550-22-2 | In distribution | |
| PF 4510-04-2 | In distribution | |
| PK 3542-10-2 | In distribution | |
| PH 3544-11-2 | In distribution | |
| PH 3521-07-2 | In distribution | |
| PA 4532-10-2 | In distribution | |
| PA 3523-06-2 | In distribution | |
| PA 3524-06-2 | In distribution | |
| PH 3541-07-2 | In distribution | |
| PR 2521-05-2 | In distribution | |
| PG 4556-10-2 | In distribution | |
| PH 3533-05-2 | In distribution | |
| PA 3524-08-2 | In distribution | |
| PG 4555-18-2 | In distribution | |
| PA 3533-08-2 | In distribution | |
| PF 2545-06-2 | In distribution | |
| PA 3522-10-2 | In distribution | |
| PU 3533-08-2 | In distribution | |
| PH 3534-07-2 | In distribution | |
| PR 3550-09-2 | In distribution | |
| PH 3510-05-2 | In distribution | |
| PA 3562-10-2 | In distribution | |
| PH 3544-03-2 | In distribution | |
| PF 4510-13-2 | In distribution | |
| PG 3553-10-2 | In distribution | |
| PA 3522-14-2 | In distribution | |
| PG 4555-10-2 | In distribution | |
| PR 3550-12-2 | In distribution | |
| PA 3532-06-2 | In distribution | |
| PH 3532-07-2 | In distribution | |
| PU 3533-04-2 | In distribution | |
| PA 3524-14-2 | In distribution | |
| PG 4556-18-2 | In distribution | |
| PF 2544-03-2 | In distribution | |
| PG 4555-08-2 | In distribution | |
| PF 3512-60-2 | In distribution | |
| PR 2512-04-2 | In distribution | |
| PG 3555-04-2 | In distribution | |
| PA 3541-07-2 | In distribution | |
| PG 4555-09-2 | In distribution | |
| PH 3524-07-2 | In distribution | |
| PU 3532-08-2 | In distribution | |
| PU 3534-06-2 | In distribution | |
| PH 3524-03-2 | In distribution | |
| PA 3532-10-2 | In distribution | |
| PG 4556-14-2 | In distribution | |
| PR 2511-04-2 | In distribution | |
| PG 4555-22-2 | In distribution | |
| PU 3531-04-2 | In distribution | |
| PR 2542-06-2 | In distribution | |
| PR 2521-04-2 | In distribution | |
| PH 3522-05-2 | In distribution | |
| PA 3562-08-2 | In distribution | |
| PH 3543-05-2 | In distribution | |
| PG 3553-06-2 | In distribution | |
| PH 3541-11-2 | In distribution | |
| PU 3534-02-2 | In distribution | |
| PA 3561-04-2 | In distribution | |
| PF 4511-04-2 | In distribution | |
| PA 3531-06-2 | In distribution | |
| PK 3522-10-2 | In distribution | |
| PA 3563-04-2 | In distribution | |
| PG 4555-12-2 | In distribution | |
| PF 3511-70-2 | In distribution | |
| PH 3522-07-2 | In distribution | |
| PR 2550-06-2 | In distribution | |
| PR 2522-05-2 | In distribution | |
| PA 3564-06-2 | In distribution | |
| PH 3531-07-2 | In distribution | |
| PG 3555-16-2 | In distribution | |
| PH 3542-11-2 | In distribution | |
| PA 3523-04-2 | In distribution | |
| PF 3512-70-2 | In distribution | |
| PA 3531-04-2 | In distribution | |
| PA 3564-03-2 | In distribution | |
| PK 3511-05-2 | In distribution | |
| PA 3533-12-2 | In distribution | |
| PA 3533-14-2 | In distribution | |
| PF 2531-06-2 | In distribution | |
| PH 3533-02-2 | In distribution | |
| PA 3521-14-2 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
|---|---|
| K254253 | 2026-03-24 |
| K230141 | 2023-03-17 |
| K211582 | 2021-10-18 |
| K210043 | 2021-03-03 |
| K182818 | 2019-08-01 |
| K182785 | 2019-06-19 |
| K161696 | 2016-11-23 |
| K161747 | 2016-11-22 |
| K161703 | 2016-11-04 |
| K153034 | 2016-01-21 |
| K141823 | 2014-08-07 |
| K140607 | 2014-05-08 |
| K133675 | 2014-01-23 |
| K132787 | 2013-12-24 |
| K131782 | 2013-11-18 |
| K132554 | 2013-10-03 |
| K123875 | 2013-03-11 |
| K121495 | 2012-12-07 |
| K121494 | 2012-11-19 |
| K113601 | 2012-11-08 |
| K113602 | 2012-10-31 |
| K113648 | 2012-09-06 |
| K113652 | 2012-08-30 |
| K072411 | 2008-03-20 |
| K030909 | 2003-04-10 |
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.