Axle Interspinous Fusion System
IRIX-A INTEGRATED SPACER, TITANIUM, 33 X 26 X 12°, 17mm (STERILE), CE MARKED
3manufacturers in China registered for this device type
190catalogue numbers in this listing
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 | Xtant Medical Holdings, 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 |
| Record published | 2015-10-30 |
| Record revised | 2025-07-14 (version 6) |
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 |
| Sizes | Length 26 to 30 mm; angle 8 to 12 °; width 33 to 42 mm; height 11 to 19 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X080-382815-08 | Length 28 mm | In distribution |
| X080-332611-12TPC-STR | Width 33 mm | In distribution |
| X080-332617-12T-STRX | Length 26 mm | In distribution |
| X080-382819-12T-STR | Height 19 mm | In distribution |
| X080-423011-08T-STR | Angle 8 ° | In distribution |
| X080-332615-12 | Length 26 mm | In distribution |
| X080-423013-08X | Height 13 mm | In distribution |
| X080-332615-08T-STRX | Width 33 mm | In distribution |
| X080-423019-08 | Width 42 mm | In distribution |
| X080-423013-12PC | Width 42 mm | In distribution |
| X080-423015-08 | Angle 8 ° | In distribution |
| X080-382819-08TPC-STR | Length 28 mm | In distribution |
| X080-382819-08 | Width 38 mm | In distribution |
| X080-332611-12T-STR | Angle 12 ° | In distribution |
| X080-423015-08TPC-STR | Height 15 mm | In distribution |
| X080-382811-08 | Width 38 mm | In distribution |
| X080-382815-08T-STR | Width 38 mm | In distribution |
| X080-382813-12PCX | Angle 12 ° | In distribution |
| X080-423015-12 | Height 15 mm | In distribution |
| X080-332617-08 | Height 17 mm | In distribution |
| X080-423015-12TPC-STR | Width 42 mm | In distribution |
| X080-423015-08T-STR | Height 15 mm | In distribution |
| X080-382819-12X | Length 28 mm | In distribution |
| X080-382819-08X | Length 28 mm | In distribution |
| X080-423011-08PC | Angle 8 ° | In distribution |
| X080-332613-12T-STR | Height 13 mm | In distribution |
| X080-332619-12T-STR | Angle 12 ° | In distribution |
| X080-332611-08T-STRX | Width 33 mm | In distribution |
| X080-332611-08 | Height 11 mm | In distribution |
| X080-382819-08T-STR | Height 19 mm | In distribution |
| X080-423019-12TPC-STR | Length 30 mm | In distribution |
| X080-382811-12 | Height 11 mm | In distribution |
| X080-423011-12T-STR | Width 42 mm | In distribution |
| X080-332619-08T-STR | Height 19 mm | In distribution |
| X080-423019-12T-STR | Angle 12 ° | In distribution |
| X080-423019-08X | Length 30 mm | In distribution |
| X080-382819-08PCX | Angle 8 ° | In distribution |
| X080-382813-08PC | Width 38 mm | In distribution |
| X080-332619-12PC | Width 33 mm | In distribution |
| X080-382813-12PC | Width 38 mm | In distribution |
| X080-423017-08 | Width 42 mm | In distribution |
| X080-332613-08 | Angle 8 ° | In distribution |
| X080-332613-12PC | Angle 12 ° | In distribution |
| X080-332613-12TPC-STR | Height 13 mm | In distribution |
| X080-332611-08X | Height 11 mm | In distribution |
| X080-382815-12TPC-STR | Angle 12 ° | In distribution |
| X080-382811-08PCX | Angle 8 ° | In distribution |
| X080-332619-08TPC-STR | Angle 8 ° | In distribution |
| X080-382815-12T-STR | Length 28 mm | In distribution |
| X080-423017-12T-STR | Height 17 mm | In distribution |
| X080-423019-08PCX | Height 19 mm | In distribution |
| X080-332617-08T-STR | Length 26 mm | In distribution |
| X080-382813-08X | Angle 8 ° | In distribution |
| X080-382817-12PCX | Height 17 mm | In distribution |
| X080-423019-08T-STR | Width 42 mm | In distribution |
| X080-382811-12T-STR | Angle 12 ° | In distribution |
| X080-423013-12PCX | Angle 12 ° | In distribution |
| X080-332613-08T-STR | Width 33 mm | In distribution |
| X080-382815-08PC | Length 28 mm | In distribution |
| X080-332615-08TPC-STR | Angle 8 ° | In distribution |
| X080-423013-12T-STR | Length 30 mm | In distribution |
| X080-423015-08X | Length 30 mm | In distribution |
| X080-332613-08T-STRX | Angle 8 ° | In distribution |
| X080-332611-12T-STRX | Width 33 mm | In distribution |
| X080-423011-08 | Length 30 mm | In distribution |
| X080-423011-08TPC-STR | Length 30 mm | In distribution |
| X080-382815-12PC | Width 38 mm | In distribution |
| X080-423017-08PCX | Angle 8 ° | In distribution |
| X080-382815-12 | Width 38 mm | In distribution |
| X080-423017-12PCX | Width 42 mm | In distribution |
| X080-423013-08 | Length 30 mm | In distribution |
| X080-382811-08PC | Length 28 mm | In distribution |
| X080-423013-12 | Length 30 mm | In distribution |
| X080-423017-12X | Height 17 mm | In distribution |
| X080-332615-08PC | Width 33 mm | In distribution |
| X080-382813-08TPC-STR | Angle 8 ° | In distribution |
| X080-382815-08X | Length 28 mm | In distribution |
| X080-382817-08 | Angle 8 ° | In distribution |
| X080-332611-12 | Length 26 mm | In distribution |
| X080-332611-08TPC-STR | Height 11 mm | In distribution |
| X080-423017-12 | Length 30 mm | In distribution |
| X080-332615-08X | Height 15 mm | In distribution |
| X080-332619-12T-STRX | Width 33 mm | In distribution |
| X080-332619-12X | Height 19 mm | In distribution |
| X080-423019-08TPC-STR | Length 30 mm | In distribution |
| X080-382811-12TPC-STR | Height 11 mm | In distribution |
| X080-332615-12PCX | Width 33 mm | In distribution |
| X080-332611-12X | Length 26 mm | In distribution |
| X080-382817-08PC | Height 17 mm | In distribution |
| X080-423015-12T-STR | Height 15 mm | In distribution |
| X080-423011-08PCX | Width 42 mm | In distribution |
| X080-382817-12 | Angle 12 ° | In distribution |
| X080-423011-12PCX | Length 30 mm | In distribution |
| X080-423019-08PC | Length 30 mm | In distribution |
| X080-382817-12T-STR | Length 28 mm | In distribution |
| X080-332619-12 | Length 26 mm | In distribution |
| X080-332615-08 | Length 26 mm | In distribution |
| X080-332613-08X | Length 26 mm | In distribution |
| X080-423011-12PC | Length 30 mm | In distribution |
| X080-332619-08PC | Width 33 mm | In distribution |
| X080-332613-08TPC-STR | Width 33 mm | In distribution |
| X080-332615-12PC | Width 33 mm | In distribution |
| X080-423017-08PC | Length 30 mm | In distribution |
| X080-382817-12TPC-STR | Length 28 mm | In distribution |
| X080-332619-08 | Length 26 mm | In distribution |
| X080-382811-12PCX | Width 38 mm | In distribution |
| X080-332613-12T-STRX | Width 33 mm | In distribution |
| X080-423017-08X | Width 42 mm | In distribution |
| X080-423013-12X | Angle 12 ° | In distribution |
| X080-332615-12T-STR | Width 33 mm | In distribution |
| X080-423017-12TPC-STR | Length 30 mm | In distribution |
| X080-423011-08X | Height 11 mm | In distribution |
| X080-423011-12TPC-STR | Angle 12 ° | In distribution |
| X080-332617-12PC | Length 26 mm | In distribution |
| X080-382817-08PCX | Length 28 mm | In distribution |
| X080-332613-08PCX | Width 33 mm | In distribution |
| X080-332617-12X | Height 17 mm | In distribution |
| X080-382815-12X | Length 28 mm | In distribution |
| X080-382817-08T-STR | Width 38 mm | In distribution |
| X080-382815-12PCX | Height 15 mm | In distribution |
| X080-332611-08T-STR | Width 33 mm | In distribution |
| X080-423015-12X | Height 15 mm | In distribution |
| X080-382811-08T-STR | Width 38 mm | In distribution |
| X080-332617-08T-STRX | Length 26 mm | In distribution |
| X080-382813-12TPC-STR | Width 38 mm | In distribution |
| X080-382817-08X | Width 38 mm | In distribution |
| X080-332619-12TPC-STR | Angle 12 ° | In distribution |
| X080-332617-08PCX | Length 26 mm | In distribution |
| X080-382819-12PC | Length 28 mm | In distribution |
| X080-332613-08PC | Length 26 mm | In distribution |
| X080-382819-12 | Width 38 mm | In distribution |
| X080-382811-08X | Width 38 mm | In distribution |
| X080-382819-08PC | Width 38 mm | In distribution |
| X080-332617-08X | Height 17 mm | In distribution |
| X080-423013-12TPC-STR | Height 13 mm | In distribution |
| X080-332615-12T-STRX | Width 33 mm | In distribution |
| X080-382813-12T-STR | Length 28 mm | In distribution |
| X080-423017-08TPC-STR | Height 17 mm | In distribution |
| X080-423013-08T-STR | Angle 8 ° | In distribution |
| X080-423013-08TPC-STR | Width 42 mm | In distribution |
| X080-423011-12X | Height 11 mm | In distribution |
| X080-332617-12T-STR | Height 17 mm | In distribution |
| X080-332611-12PCX | Length 26 mm | In distribution |
| X080-382817-12X | Height 17 mm | In distribution |
| X080-332617-08TPC-STR | Length 26 mm | In distribution |
| X080-382817-08TPC-STR | Length 28 mm | In distribution |
| X080-382815-08PCX | Length 28 mm | In distribution |
| X080-382817-12PC | Width 38 mm | In distribution |
| X080-423015-12PC | Length 30 mm | In distribution |
| X080-382813-12 | Length 28 mm | In distribution |
| X080-332619-08X | Width 33 mm | In distribution |
| X080-423019-12PCX | Length 30 mm | In distribution |
| X080-382811-08TPC-STR | Width 38 mm | In distribution |
| X080-332613-12X | Angle 12 ° | In distribution |
| X080-382813-08 | Width 38 mm | In distribution |
| X080-423019-12PC | Angle 12 ° | In distribution |
| X080-332611-08PC | Width 33 mm | In distribution |
| X080-382811-12X | Angle 12 ° | In distribution |
| X080-332613-12 | Length 26 mm | In distribution |
| X080-332611-12PC | Angle 12 ° | In distribution |
| X080-332619-08T-STRX | Angle 8 ° | In distribution |
| X080-332617-12TPC-STR | Angle 12 ° | In distribution |
| X080-423011-12 | Width 42 mm | In distribution |
| X080-382813-08PCX | Angle 8 ° | In distribution |
| X080-332615-12TPC-STR | Height 15 mm | In distribution |
| X080-423019-12X | Width 42 mm | In distribution |
| X080-382813-08T-STR | Angle 8 ° | In distribution |
| X080-332613-12PCX | Width 33 mm | In distribution |
| X080-423017-12PC | Angle 12 ° | In distribution |
| X080-332615-08T-STR | Length 26 mm | In distribution |
| X080-382813-12X | Angle 12 ° | In distribution |
| X080-382811-12PC | Width 38 mm | In distribution |
| X080-332615-12X | Length 26 mm | In distribution |
| X080-423013-08PCX | Angle 8 ° | In distribution |
| X080-423015-12PCX | Angle 12 ° | In distribution |
| X080-382815-08TPC-STR | Angle 8 ° | In distribution |
| X080-332619-08PCX | Height 19 mm | In distribution |
| X080-332617-12PCX | Width 33 mm | In distribution |
| X080-332619-12PCX | Height 19 mm | In distribution |
| X080-382819-12TPC-STR | Angle 12 ° | In distribution |
| X080-332611-08PCX | Angle 8 ° | In distribution |
| X080-423013-08PC | Length 30 mm | In distribution |
| X080-423019-12 | Length 30 mm | In distribution |
| X080-332615-08PCX | Angle 8 ° | In distribution |
| X080-382819-12PCX | Width 38 mm | In distribution |
| X080-423015-08PCX | Angle 8 ° | In distribution |
| X080-423017-08T-STR | Length 30 mm | In distribution |
| X080-423015-08PC | Width 42 mm | In distribution |
| X080-332617-08PC | Length 26 mm | In distribution |
| X080-332617-12 | Length 26 mm | 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
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 |
|---|---|---|---|---|
| 2025-01-03 | Class II | Labeling Change Control | Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date. | 14 units |
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.