Earp Instruments
EARP INSTRUMENT AND IMPLANT TRAY. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD)…
EARP INSTRUMENT AND IMPLANT TRAY. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (8), Zhejiang (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Guangdong Huilin Packaging Technology Group Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Showing 12 of 36. All 36 manufacturers in China registered for Tray, Surgical
Record
| Listed by | Nvision Biomedical Technologies, Inc, United States |
|---|---|
| FDA product code | LRP |
| Device type | Tray, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-18 |
| Record revised | 2026-07-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EARP-TRAY01-XXX | In distribution | |
| EARP-IC_1430 | In distribution | |
| EARP-IC_1440 | In distribution | |
| EARP-IC_1840 | In distribution | |
| EARP-IC_2235 | In distribution | |
| EARP-IC_1845 | In distribution | |
| EARP-IC_2240 | In distribution | |
| EARP-IC_2245 | In distribution | |
| EARP-IC_1435 | In distribution | |
| EARP-TRAY02-XXX | In distribution | |
| EARP-TC | In distribution | |
| EARP-IC_1835 | In distribution | |
| EARP-IC_1425 | In distribution | |
| EARP-DC | In distribution | |
| EARP-IC_1830 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 12,037 |
| Centurion | Centurion Medical Products Corporation | 2,023 |
| Medline | Medline Industries, Inc. | 773 |
| PST Trays | Ambler Surgical, LLC | 128 |
| AngioSystems Tray | Angiosystems, Inc. | 126 |
| Tray, Surgical | Wright Medical Technology, Inc. | 123 |
| Medin Corporation | Ambler Surgical, LLC | 96 |
| Aligned Medical Solutions | Aligned Medical Solutions | 92 |
| Stradis | Stradis Healthcare | 91 |
| Cortera Spinal Fixation System | Xtant Medical Holdings, Inc. | 90 |
| SteriBest | Surgical Products Corp. | 84 |
| Elmed | Elmed, Inc. | 79 |
Showing 12 of 808. All products under Tray, Surgical
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.