AMP-LTX
AMP-LTX Plate, 2-Hole Offset Right with Center Screw
3manufacturers in China registered for this device type
71catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Shandong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Alphatec Spine, Inc., United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K242147 |
| Record published | 2024-12-09 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 5 to 6 mm; length 25 to 65 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 612-50-50-2-S | Outer Diameter 5.0 mm | In distribution |
| 612-55-50 | In distribution | |
| 612-2-102 | In distribution | |
| 622-2-201-S | In distribution | |
| 612-60-35-2-S | Length 35 mm | In distribution |
| 612-55-25-2-S | Outer Diameter 5.5 mm | In distribution |
| 612-60-30-2-S | Outer Diameter 6.0 mm | In distribution |
| 622-2-201 | In distribution | |
| 612-50-25 | In distribution | |
| 612-60-55-2-S | Outer Diameter 6.0 mm | In distribution |
| 612-50-40 | In distribution | |
| 612-55-65-2-S | Outer Diameter 5.5 mm | In distribution |
| 612-60-40 | In distribution | |
| 620-111 | In distribution | |
| 612-50-35-2-S | Length 35 mm | In distribution |
| 612-2-202 | In distribution | |
| 612-55-40-2-S | Length 40 mm | In distribution |
| 612-55-45 | In distribution | |
| 622-2-202 | In distribution | |
| 612-60-50 | In distribution | |
| 612-55-40 | In distribution | |
| 612-55-55 | In distribution | |
| 622-2-101-S | In distribution | |
| 612-60-55 | In distribution | |
| 612-60-65 | In distribution | |
| 612-60-30 | In distribution | |
| 612-2-200 | In distribution | |
| 612-55-35 | In distribution | |
| 612-50-25-2-S | Outer Diameter 5.0 mm | In distribution |
| 612-50-40-2-S | Outer Diameter 5.0 mm | In distribution |
| 612-55-60 | In distribution | |
| 612-60-25-2-S | Outer Diameter 6.0 mm | In distribution |
| 612-50-35 | In distribution | |
| 612-2-001 | In distribution | |
| 612-60-45 | In distribution | |
| 622-2-200-S | In distribution | |
| 612-60-60-2-S | Length 60 mm | In distribution |
| 612-60-60 | In distribution | |
| 612-50-30 | In distribution | |
| 612-50-60-2-S | Length 60 mm | In distribution |
| 612-55-30 | In distribution | |
| 622-2-102-S | In distribution | |
| 612-55-60-2-S | Outer Diameter 5.5 mm | In distribution |
| 612-50-45-2-S | Outer Diameter 5.0 mm | In distribution |
| 612-50-65 | In distribution | |
| 612-50-55-2-S | Length 55 mm | In distribution |
| 612-55-35-2-S | Outer Diameter 5.5 mm | In distribution |
| 612-60-65-2-S | Length 65 mm | In distribution |
| 612-50-30-2-S | Length 30 mm | In distribution |
| 612-60-45-2-S | Length 45 mm | In distribution |
| 612-60-50-2-S | Outer Diameter 6.0 mm | In distribution |
| 612-55-25 | In distribution | |
| 612-50-60 | In distribution | |
| 612-60-40-2-S | Outer Diameter 6.0 mm | In distribution |
| 622-2-102 | In distribution | |
| 612-50-50 | In distribution | |
| 612-2-201 | In distribution | |
| 612-2-101 | In distribution | |
| 612-50-45 | In distribution | |
| 612-50-65-2-S | Outer Diameter 5.0 mm | In distribution |
| 612-55-45-2-S | Length 45 mm | In distribution |
| 612-55-55-2-S | Outer Diameter 5.5 mm | In distribution |
| 610-110 | In distribution | |
| 612-55-30-2-S | Length 30 mm | In distribution |
| 612-55-50-2-S | Length 50 mm | In distribution |
| 612-60-25 | In distribution | |
| 622-2-200 | In distribution | |
| 612-55-65 | In distribution | |
| 622-2-202-S | In distribution | |
| 612-60-35 | In distribution | |
| 612-50-55 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sirion | Astura Medical | 1,465 |
| IdentiTi | Alphatec Spine, Inc. | 1,372 |
| EL Capitan | Astura Medical | 1,205 |
| Zavation | Zavation | 1,157 |
| Brigade | Nuvasive, Inc. | 1,005 |
| Solar™ Interbody Fusion System | Degen Medical | 899 |
| Zavation F3D Corpectomy | Zavation | 730 |
| ROI-A | Ldr Spine USA | 552 |
| Avenue L | Ldr Spine USA | 524 |
| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251575 | 2025-09-03 |
| K232097 | 2023-09-25 |
| K203742 | 2021-04-09 |
| K123993 | 2013-03-05 |
| K102402 | 2011-03-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-01-26 | Class II | Device Design | Due to reports of intraoperative graft bolt implantation breakages. | 12,777 devices |
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.