Epic
4.5mm NON-LOCKING SCREW x 60mm
22manufacturers in China registered for this device type
135catalogue numbers in this listing
3510(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 | Exactech, Inc., United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K182991 |
| Record published | 2024-01-11 |
| Record revised | 2025-11-20 (version 3) |
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 |
| Sizes | Length 16 to 83 mm; outer diameter 3.5 to 5.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2000-5520 | Length 20 mm | In distribution |
| 2000-4522 | Outer Diameter 4.5 mm | In distribution |
| 2000-8001 | In distribution | |
| 2000-5548 | Length 48 mm | In distribution |
| 2000-3548 | Outer Diameter 3.5 mm | In distribution |
| 2001-4560 | Length 60 mm | In distribution |
| 2001-5562 | Length 62 mm | In distribution |
| 2001-4532 | Outer Diameter 4.5 mm | In distribution |
| 2001-5564 | Length 64 mm | In distribution |
| 2001-4568 | Outer Diameter 4.5 mm | In distribution |
| 2000-4534 | Length 34 mm | In distribution |
| 2000-4550 | Outer Diameter 4.5 mm | In distribution |
| 2000-4530 | Outer Diameter 4.5 mm | In distribution |
| 2001-4555 | Outer Diameter 4.5 mm | In distribution |
| 2001-4552 | Length 52 mm | In distribution |
| 2000-3546 | Outer Diameter 3.5 mm | In distribution |
| 2000-4546 | Length 46 mm | In distribution |
| 2000-4570 | Length 70 mm | In distribution |
| 2001-5536 | Length 36 mm | In distribution |
| 2000-4516 | Length 16 mm | In distribution |
| 2001-4564 | Outer Diameter 4.5 mm | In distribution |
| 2001-4554 | Outer Diameter 4.5 mm | In distribution |
| 2001-5566 | Length 66 mm | In distribution |
| 2001-5542 | Outer Diameter 5.5 mm | In distribution |
| 2000-4556 | Outer Diameter 4.5 mm | In distribution |
| 2000-4566 | Length 66 mm | In distribution |
| 2001-5524 | Length 24 mm | In distribution |
| 2001-5544 | Outer Diameter 5.5 mm | In distribution |
| 2000-3554 | Outer Diameter 3.5 mm | In distribution |
| 2000-4526 | Outer Diameter 4.5 mm | In distribution |
| 2000-4528 | Length 28 mm | In distribution |
| 2000-4520 | Length 20 mm | In distribution |
| 2000-4544 | Outer Diameter 4.5 mm | In distribution |
| 2000-4542 | Length 42 mm | In distribution |
| 2000-4564 | Outer Diameter 4.5 mm | In distribution |
| 2000-5538 | Outer Diameter 5.5 mm | In distribution |
| 2000-4568 | Outer Diameter 4.5 mm | In distribution |
| 2000-5526 | Outer Diameter 5.5 mm | In distribution |
| 2001-4544 | Outer Diameter 4.5 mm | In distribution |
| 2001-4516 | Outer Diameter 4.5 mm | In distribution |
| 2000-4524 | Length 24 mm | In distribution |
| 2001-5570 | Length 70 mm | In distribution |
| 2000-4565 | Length 65 mm | In distribution |
| 2001-5522 | Outer Diameter 5.5 mm | In distribution |
| 2001-5526 | Length 26 mm | In distribution |
| 2000-5570 | Outer Diameter 5.5 mm | In distribution |
| 2001-4562 | Outer Diameter 4.5 mm | In distribution |
| 2000-8002 | In distribution | |
| 2000-8008 | LONG | In distribution |
| 2000-3544 | Outer Diameter 3.5 mm | In distribution |
| 2000-8006 | LONG | In distribution |
| 2001-4570 | Outer Diameter 4.5 mm | In distribution |
| 2000-4545 | Outer Diameter 4.5 mm | In distribution |
| 2000-5565 | Length 65 mm | In distribution |
| 2000-5528 | Length 28 mm | In distribution |
| 2000-8007 | STD | In distribution |
| 2000-4562 | Outer Diameter 4.5 mm | In distribution |
| 2001-4545 | Length 45 mm | In distribution |
| 2001-5546 | Outer Diameter 5.5 mm | In distribution |
| 2000-4536 | Outer Diameter 4.5 mm | In distribution |
| 2000-5540 | Outer Diameter 5.5 mm | In distribution |
| 2001-5532 | Outer Diameter 5.5 mm | In distribution |
| 2001-4542 | Outer Diameter 4.5 mm | In distribution |
| 2000-5560 | Length 60 mm | In distribution |
| 2001-5565 | Length 65 mm | In distribution |
| 2001-4546 | Length 46 mm | In distribution |
| 2000-8009 | STD | In distribution |
| 2000-8003 | STD | In distribution |
| 2000-4532 | Length 32 mm | In distribution |
| 2000-8005 | STD | In distribution |
| 2000-5530 | Outer Diameter 5.5 mm | In distribution |
| 2000-4560 | Outer Diameter 4.5 mm | In distribution |
| 2001-4518 | Length 18 mm | In distribution |
| 2001-5534 | Length 34 mm | In distribution |
| 2001-5555 | Outer Diameter 5.5 mm | In distribution |
| 2001-4548 | Length 48 mm | In distribution |
| 2001-4566 | Length 66 mm | In distribution |
| 2000-8004 | LONG | In distribution |
| 2001-4558 | Length 58 mm | In distribution |
| 2001-5556 | Length 56 mm | In distribution |
| 2000-5568 | Length 68 mm | In distribution |
| 2000-3556 | Outer Diameter 3.5 mm | In distribution |
| 2000-3542 | Length 42 mm | In distribution |
| 2001-5560 | Length 60 mm | In distribution |
| 2001-5548 | Length 48 mm | In distribution |
| 2001-4528 | Outer Diameter 4.5 mm | In distribution |
| 2001-5568 | Length 68 mm | In distribution |
| 2000-4555 | Length 55 mm | In distribution |
| 2000-5534 | Length 34 mm | In distribution |
| 2000-3558 | Outer Diameter 3.5 mm | In distribution |
| 2000-5550 | Outer Diameter 5.5 mm | In distribution |
| 2000-5562 | Outer Diameter 5.5 mm | In distribution |
| 2000-5536 | Outer Diameter 5.5 mm | In distribution |
| 2000-5524 | Length 24 mm | In distribution |
| 2000-4558 | Length 58 mm | In distribution |
| 2001-5552 | Length 52 mm | In distribution |
| 2000-5522 | Length 22 mm | In distribution |
| 2001-5528 | Outer Diameter 5.5 mm | In distribution |
| 2001-4565 | Outer Diameter 4.5 mm | In distribution |
| 2001-4540 | Length 40 mm | In distribution |
| 2001-4530 | Length 30 mm | In distribution |
| 2000-8011 | Length 66 mm | In distribution |
| 2000-5566 | Outer Diameter 5.5 mm | In distribution |
| 2000-5555 | Length 55 mm | In distribution |
| 2001-5538 | Length 38 mm | In distribution |
| 2001-4556 | Outer Diameter 4.5 mm | In distribution |
| 2001-4522 | Length 22 mm | In distribution |
| 2001-5530 | Length 30 mm | In distribution |
| 2001-5554 | Outer Diameter 5.5 mm | In distribution |
| 2000-4552 | Outer Diameter 4.5 mm | In distribution |
| 2000-4554 | Outer Diameter 4.5 mm | In distribution |
| 2000-8012 | Length 83 mm | In distribution |
| 2000-5546 | Outer Diameter 5.5 mm | In distribution |
| 2000-4548 | Outer Diameter 4.5 mm | In distribution |
| 2001-4520 | Length 20 mm | In distribution |
| 2000-5564 | Outer Diameter 5.5 mm | In distribution |
| 2001-5558 | Outer Diameter 5.5 mm | In distribution |
| 2001-4550 | Outer Diameter 4.5 mm | In distribution |
| 2000-5532 | Length 32 mm | In distribution |
| 2001-5540 | Outer Diameter 5.5 mm | In distribution |
| 2000-4538 | Length 38 mm | In distribution |
| 2000-8010 | LONG | In distribution |
| 2001-4536 | Outer Diameter 4.5 mm | In distribution |
| 2000-4540 | Length 40 mm | In distribution |
| 2000-3560 | Outer Diameter 3.5 mm | In distribution |
| 2000-4518 | Outer Diameter 4.5 mm | In distribution |
| 2001-4538 | Outer Diameter 4.5 mm | In distribution |
| 2001-4526 | Outer Diameter 4.5 mm | In distribution |
| 2000-5542 | Length 42 mm | In distribution |
| 2001-5550 | Length 50 mm | In distribution |
| 2000-5544 | Outer Diameter 5.5 mm | In distribution |
| 2001-5520 | Outer Diameter 5.5 mm | In distribution |
| 2001-4524 | Outer Diameter 4.5 mm | In distribution |
| 2001-4534 | Length 34 mm | In distribution |
| 2000-3552 | Length 52 mm | 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 |
|---|---|
| K243275 | 2025-06-26 |
| K223933 | 2023-09-25 |
| K093978 | 2010-05-11 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Epic Extremity, LLC | 510(k) number | 2018-03-20 | Class II | Error in labeling | There is an error in the caddy artwork that misidentifies a specific plate and screw. | 6 units | 2019-04-25 |
| Epic Extremity, LLC | 510(k) number | 2018-03-20 | Class II | Error in labeling | There is an error in the caddy artwork that misidentifies a specific plate and screw. | 9 units | 2019-04-25 |
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.