ActivaPin™
ActivaPin™ 1.5 mm x 20 mm
12manufacturers in China registered for this device type
36catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Zhejiang (2). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Aplus (Guangzhou) Medical Technology Company | Guangzhou | Guangdong | Contract manufacturer | 6 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Bioretec Ltd., Finland |
|---|---|
| FDA product code | HTY |
| Device type | Pin, Fixation, Smooth |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K080879 |
| Record published | 2015-08-25 |
| Record revised | 2026-01-23 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 59 to 86 °F; Storage environment temperature 15 to 30 °C |
| Sizes | Width 1.5 to 3.2 mm; length 20 to 70 mm |
| Distribution end date | 2023-11-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B-AP-1520 | Width 1.5 mm | In distribution |
| B-AP-2770 | Length 70 mm | In distribution |
| B-AP-2070 | Width 2.0 mm | In distribution |
| B-AP-1530 | Length 30 mm | In distribution |
| B-AP-1540 | Width 1.5 mm | In distribution |
| B-AP-2030 | Width 2.0 mm | In distribution |
| B-AP-3270 | Width 3.2 mm | In distribution |
| B-AP-1530 | Length 30 mm | In distribution |
| B-AP-1560 | Width 1.5 mm | In distribution |
| B-AP-1550 | Length 50 mm | In distribution |
| B-AP-2060 | Length 60 mm | In distribution |
| B-AP-1520 | Width 1.5 mm | In distribution |
| B-AP-2060 | Length 60 mm | In distribution |
| B-AP-2050 | Width 2.0 mm | In distribution |
| B-AP-1560 | Width 1.5 mm | In distribution |
| B-AP-2770 | Length 70 mm | In distribution |
| B-AP-1570 | Length 70 mm | In distribution |
| B-AP-1540 | Width 1.5 mm | In distribution |
| B-AP-2020 | Length 20 mm | In distribution |
| B-AP-2050 | Width 2.0 mm | In distribution |
| B-AP-3270 | Width 3.2 mm | In distribution |
| B-AP-1570 | Length 70 mm | In distribution |
| B-AP-2040 | Length 40 mm | In distribution |
| B-AP-2040 | Length 40 mm | In distribution |
| B-AP-2070 | Width 2.0 mm | In distribution |
| B-AP-1550 | Length 50 mm | In distribution |
| B-AP-2020 | Length 20 mm | In distribution |
| B-AP-2750 | Length 50 mm | In distribution |
| B-AP-2750 | Length 50 mm | In distribution |
| B-AP-2030 | Width 2.0 mm | In distribution |
| B-AP-3260 | Length 60 mm | Withdrawn |
| B-AP-3240 | Length 40 mm | Withdrawn |
| B-AP-2760 | Width 2.7 mm | Withdrawn |
| B-AP-2730 | Length 30 mm | Withdrawn |
| B-AP-3250 | Width 3.2 mm | Withdrawn |
| B-AP-2740 | Width 2.7 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rondo’ | Citieffe SRL | 265 |
| HNM Medical | HNM Stainless, LLC. | 232 |
| Kmedic | Teleflex Medical LLC | 227 |
| gSource | Gsource, LLC. | 221 |
| MicroAire® | Microaire Surgical Instruments LLC | 213 |
| Orthomed | Ortho-MED, Inc. | 163 |
| mahe medical GmbH | Mahe Intl., Inc. | 160 |
| Pin, Fixation, Smooth | Key Surgical, LLC | 134 |
| Pin, Fixation, Smooth | Stryker GmbH | 134 |
| Aptus | Medartis Inc. | 134 |
| Key Surgical K-Wires and Steinmann Pins | Key Surgical, LLC | 126 |
| PedFlex Flexible Nailing System | Orthopediatrics, Corp | 119 |
Showing 12 of 682. All products under Pin, Fixation, Smooth
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133950 | 2014-01-22 |
| K080879 | 2008-06-24 |
| K071863 | 2007-08-31 |
| K061164 | 2006-07-06 |
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.