EL Capitan
CUP Currette, Oblique, High Offset Cranial, Serrated, #2
3manufacturers in China registered for this device type
1,205catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Astura Medical, 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 |
| Record published | 2021-07-29 |
| Record revised | 2025-12-10 (version 6) |
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 | Angle 0 to 90 °; height 9.5 to 21 mm; width 5 to 42 mm; length 5.5 to 42 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KDC13000B | Angle 15 ° | In distribution |
| KZF02D21A | Height 21 mm | In distribution |
| KI382821C | Length 38 mm | In distribution |
| KA422811B | Width 42 mm | In distribution |
| KA302413A | Width 30 mm | In distribution |
| KZA10BQ06 | In distribution | |
| KI342617D | Length 34 mm | In distribution |
| KG342617B | Width 34 mm | In distribution |
| KB302417B | Width 30 mm | In distribution |
| KZB03B17E | Height 17 mm | In distribution |
| KB422819C | Width 42 mm | In distribution |
| KZF02C21D | Height 21 mm | In distribution |
| KB342611E | Width 34 mm | In distribution |
| KZB990000-80 | Angle 20 ° | In distribution |
| KG302421A | Width 30 mm | In distribution |
| KZD1600DA | Height 9.5 mm | In distribution |
| KB302411D | Width 30 mm | In distribution |
| KDC11000B | Angle 15 ° | In distribution |
| KJA15000C | Height 15 mm | In distribution |
| KB382817C | Width 38 mm | In distribution |
| KB342615A | Width 34 mm | In distribution |
| KH422817A | Length 42 mm | In distribution |
| KZA15BF04 | In distribution | |
| KZB03A15B | Height 15 mm | In distribution |
| KZA180013 | Width 13 mm | In distribution |
| KDA21000E | Angle 30 ° | In distribution |
| KH302417C | Length 30 mm | In distribution |
| KB342617D | Width 34 mm | In distribution |
| KZB03C19B | Height 19 mm | In distribution |
| KZB03B13E | Height 13 mm | In distribution |
| KEAA50025 | Width 5 mm | In distribution |
| KG342621B | Width 34 mm | In distribution |
| KDC19000D | Height 19 mm | In distribution |
| KZF02A13C | Height 13 mm | In distribution |
| KZB990000-76 | Angle 15 ° | In distribution |
| KF0000025 | Width 5.5 mm | In distribution |
| KZB990000-75 | Angle 15 ° | In distribution |
| KZA14SV04 | Angle 90 ° | In distribution |
| KZB070000 | In distribution | |
| KG422821B | Length 42 mm | In distribution |
| KB422819D | Width 42 mm | In distribution |
| KZF02C15A | Height 15 mm | In distribution |
| KZB03C13C | Height 13 mm | In distribution |
| KZB990000-108 | In distribution | |
| KZF02C13C | Height 15 mm | In distribution |
| KZD1600DB | Height 11 mm | In distribution |
| KJB21000C | Height 21 mm | In distribution |
| KB422815A | Width 42 mm | In distribution |
| KK00C1308 | Width 13 mm | In distribution |
| KI342615D | Length 34 mm | In distribution |
| KJC15000A | Height 15 mm | In distribution |
| KB302411E | Width 30 mm | In distribution |
| KJD21000B | Height 21 mm | In distribution |
| KA342619A | Width 34 mm | In distribution |
| KZB990000-65 | Angle 30 ° | In distribution |
| KI382815A | Length 38 mm | In distribution |
| KZA15SZ04 | In distribution | |
| KJB21000A | Height 21 mm | In distribution |
| KJB17000E | Height 17 mm | In distribution |
| KB342615D | Width 34 mm | In distribution |
| KZB03C21A | Height 21 mm | In distribution |
| KH422819B | Length 42 mm | In distribution |
| KZB040000 | In distribution | |
| KDB11000C | Angle 20 ° | In distribution |
| KZB03A13A | Height 13 mm | In distribution |
| KZB9900000-20 | In distribution | |
| KZF02A15C | Height 15 mm | In distribution |
| KG302413C | Width 30 mm | In distribution |
| KH302415B | Length 30 mm | In distribution |
| KA342621B | Width 34 mm | In distribution |
| KEBB55025 | Length 5.5 mm | In distribution |
| KZD1600CA | Height 9.5 mm | In distribution |
| KJA13000A | Height 13 mm | In distribution |
| KJC21000A | Height 21 mm | In distribution |
| KDB21000E | Angle 30 ° | In distribution |
| KA382815C | Width 38 mm | In distribution |
| KJD13000A | Height 13 mm | In distribution |
| KDA17000B | Height 17 mm | In distribution |
| KZA11SZ30 | Width 30 mm | In distribution |
| KJA21000C | Height 21 mm | In distribution |
| KZF02B19A | Height 19 mm | In distribution |
| KZB990000-121 | In distribution | |
| KJA15200B | Height 15 mm | In distribution |
| KZB03C19D | Height 19 mm | In distribution |
| KG382821C | Width 38 mm | In distribution |
| KJB19000E | Height 19 mm | In distribution |
| KG422821A | Length 22 mm | In distribution |
| KA382819C | Width 38 mm | In distribution |
| KZF02A19D | Height 19 mm | In distribution |
| KB342615E | Width 34 mm | In distribution |
| KEBA50020 | Width 5 mm | In distribution |
| KL00B1308 | Width 13 mm | In distribution |
| KB382817D | Width 38 mm | In distribution |
| KZC210000 | In distribution | |
| KJA11200B | Height 11 mm | In distribution |
| KDC21000B | Height 21 mm | In distribution |
| KZB03A19B | Height 19 mm | In distribution |
| KZB03D19A | Height 19 mm | In distribution |
| KI302417E | Length 30 mm | In distribution |
| KZB03D21C | Height 21 mm | In distribution |
| KJA21200D | Height 21 mm | In distribution |
| KA422811C | Width 42 mm | In distribution |
| KG342611B | Width 34 mm | In distribution |
| KH342613B | Length 34 mm | In distribution |
| KZD1600BA | Height 9.5 mm | In distribution |
| KJD11000B | Height 11 mm | In distribution |
| KH382815A | Length 38 mm | In distribution |
| KZF02C21B | Height 21 mm | In distribution |
| KI422819D | Length 42 mm | In distribution |
| KZB03D15C | Height 15 mm | In distribution |
| KI302419D | Length 30 mm | In distribution |
| KI342613B | Length 34 mm | In distribution |
| KDB15000B | Angle 15 ° | In distribution |
| KH342615D | Length 34 mm | In distribution |
| KZB03D11B | Height 11 mm | In distribution |
| KZA14BM02 | In distribution | |
| KZB03D19C | Height 19 mm | In distribution |
| KB302415E | Width 30 mm | In distribution |
| KZB03A13C | Height 13 mm | In distribution |
| KB342613A | Width 34 mm | In distribution |
| KDA11000E | Height 11 mm | In distribution |
| KA302417B | Width 30 mm | In distribution |
| KB422811E | Width 42 mm | In distribution |
| KL00A1103 | Width 11 mm | In distribution |
| KZB990000-77 | Angle 15 ° | In distribution |
| KDA13000A | Height 13 mm | In distribution |
| KZF02A17B | Height 17 mm | In distribution |
| KZF060017 | In distribution | |
| KG342621D | Width 34 mm | In distribution |
| KZB020000 | In distribution | |
| KA342617C | Width 34 mm | In distribution |
| KZA070007 | Width 7 mm | In distribution |
| KZF02B17C | Height 17 mm | In distribution |
| KI342619D | Length 34 mm | In distribution |
| KZB03D17B | Height 17 mm | In distribution |
| KJA13000C | Height 13 mm | In distribution |
| KI342617E | Length 34 mm | In distribution |
| KZA10SZ04 | In distribution | |
| KB302413D | Width 30 mm | In distribution |
| KZB03A11B | Height 11 mm | In distribution |
| KZF090000 | In distribution | |
| KG342617E | Width 34 mm | In distribution |
| KI302413C | Length 30 mm | In distribution |
| KZA16BF04 | In distribution | |
| KDA21000C | Angle 20 ° | In distribution |
| KH342611B | Length 34 mm | In distribution |
| KA382815A | Width 38 mm | In distribution |
| KZB03C11C | Height 11 mm | In distribution |
| KZD1800BB | Height 11 mm | In distribution |
| KZB990000-101 | Angle 30 ° | In distribution |
| KK00C1103 | Width 11 mm | In distribution |
| KH342617E | Length 34 mm | In distribution |
| KZA14SQ04 | In distribution | |
| KH422811A | Length 42 mm | In distribution |
| KJA17200A | Height 17 mm | In distribution |
| KH422819A | Length 42 mm | In distribution |
| KG302417A | Width 30 mm | In distribution |
| KJA15000D | Height 15 mm | In distribution |
| KI342621C | Length 34 mm | In distribution |
| KA342615C | Width 34 mm | In distribution |
| KJA15000B | Height 15 mm | In distribution |
| KA422813C | Width 42 mm | In distribution |
| KZA19B007 | In distribution | |
| KG342621A | Width 34 mm | In distribution |
| KEBA50025 | Width 5 mm | In distribution |
| KEBB55020 | Width 5.5 mm | In distribution |
| KJA11000B | Height 11 mm | In distribution |
| KDB21000B | Angle 15 ° | In distribution |
| KZB03D11E | Height 11 mm | In distribution |
| KZF02D11B | Height 11 mm | In distribution |
| KJC17000B | Height 17 mm | In distribution |
| KI302411A | Length 30 mm | In distribution |
| KH422819E | Length 42 mm | In distribution |
| KZB03A17B | Height 17 mm | In distribution |
| KK00A9500 | Width 9.5 mm | In distribution |
| KZA080011 | Width 11 mm | In distribution |
| KZB990000-53 | Angle 8 ° | In distribution |
| KI422813A | Length 42 mm | In distribution |
| KI422815C | Length 42 mm | In distribution |
| KZB03C11E | Height 11 mm | In distribution |
| KH302421D | Length 30 mm | In distribution |
| KZB010000 | In distribution | |
| KA302421A | Width 30 mm | In distribution |
| KI342621E | Length 34 mm | In distribution |
| KA302419C | Width 30 mm | In distribution |
| KZA080019 | Width 19 mm | In distribution |
| KH302419C | Length 30 mm | In distribution |
| KB422819E | Width 42 mm | In distribution |
| KH302415D | Length 30 mm | In distribution |
| KL00D1308 | Width 13 mm | In distribution |
| KI302413B | Length 30 mm | In distribution |
| KI302419A | Length 30 mm | In distribution |
| KZF02C17D | Height 17 mm | In distribution |
| KI342621D | Length 34 mm | In distribution |
| KB342619A | Width 34 mm | In distribution |
| KI382817A | Length 38 mm | In distribution |
| KZD1800AA | Height 10 mm | In distribution |
| KG422819D | Width 42 mm | In distribution |
| KI302419E | Length 30 mm | In distribution |
| KZD1800DA | Height 10 mm | In distribution |
| KJB17000C | Height 17 mm | In distribution |
| KZB03D15D | Height 15 mm | In distribution |
| KJA13200C | Height 13 mm | In distribution |
| KB342613D | Width 34 mm | In distribution |
| KDA13000C | Height 13 mm | In distribution |
| KEAB50025 | Width 5 mm | In distribution |
| KZF02A21B | Height 21 mm | In distribution |
| KH422821E | Length 42 mm | In distribution |
| KZF02C15B | Height 15 mm | In distribution |
| KG422819E | Length 42 mm | In distribution |
| KDB15000A | Angle 8 ° | In distribution |
| KZB03B13B | Height 13 mm | In distribution |
| KB382813E | Width 38 mm | In distribution |
| KDB13000E | Angle 30 ° | In distribution |
| KZD1600DC | Height 13 mm | In distribution |
| KJB11000B | Height 11 mm | In distribution |
| KDC21000D | Height 21 mm | In distribution |
| KZB990000-61 | Angle 25 ° | In distribution |
| KJA13200B | Height 13 mm | In distribution |
| KB382819A | Width 38 mm | In distribution |
| KI382813B | Length 38 mm | In distribution |
| KJB15000A | Height 15 mm | In distribution |
| KB342619E | Width 34 mm | In distribution |
| KZB990000-57 | Angle 20 ° | In distribution |
| KZA14BE04 | In distribution | |
| KB302417A | Width 30 mm | In distribution |
| KZF060015 | In distribution | |
| KZF02B11A | Height 11 mm | In distribution |
| KZF02D21D | Height 21 mm | In distribution |
| KI342619A | Length 34 mm | In distribution |
| KI382819B | Length 38 mm | In distribution |
| KB422821A | Width 42 mm | In distribution |
| KK00B1512 | Width 15 mm | In distribution |
| KJA15200C | Height 15 mm | In distribution |
| KEAA55020 | Width 5.5 mm | In distribution |
| KG422813B | Width 42 mm | In distribution |
| KG382815B | Width 38 mm | In distribution |
| KH382815D | Length 38 mm | In distribution |
| KB422821C | Width 42 mm | In distribution |
| KNAB05525 | Length 25 mm | In distribution |
| KZF02D11A | Height 11 mm | In distribution |
| KZB03C13E | Height 13 mm | In distribution |
| KG422821D | Length 42 mm | In distribution |
| KG422817C | Width 42 mm | In distribution |
| KZF02B13C | Height 13 mm | In distribution |
| KJA13000B | Height 13 mm | In distribution |
| KZA070021 | Width 21 mm | In distribution |
| KZF02B15C | Height 15 mm | In distribution |
| KZA080015 | Width 15 mm | In distribution |
| KZF02B21B | Height 21 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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|---|---|---|
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| ROI-A | Ldr Spine USA | 552 |
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| Transcend Nanotec | Alphatec Spine, Inc. | 485 |
| Endoskeleton® TL Hyperlordotic nanoLOCK® Surface Technology | Titan Spine, LLC | 462 |
| Base | Nuvasive, Inc. | 462 |
| IDENTITi Nanotec | Alphatec Spine, Inc. | 453 |
Showing 12 of 241. All products under Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222554 | 2023-01-19 |
| K214047 | 2022-03-30 |
| K192492 | 2020-04-21 |
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.