Irix-A Lumbar Integrated Fusion System
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 15mm (STERILE)
3manufacturers in China registered for this device type
312catalogue 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 |
| Premarket notification | Exempt |
| 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, expiry date |
| Sizes | Width 33 to 42 mm; length 25 to 40 mm; angle 8 to 12 °; height 11 to 19 mm; outer diameter 5.5 to 6 mm |
| Distribution end date | 2024-11-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X080-423013-12-STRX | Width 42 mm | In distribution |
| X080-5535STX | Length 35 mm | In distribution |
| X080-382815-20PC-STR | Width 38 mm | In distribution |
| X080-382817-08-STRX | Width 38 mm | In distribution |
| X080-382819-08-STRX | Length 28 mm | In distribution |
| X080-332619-08PC-STR | Width 33 mm | In distribution |
| X080-5535SDX | Length 35 mm | In distribution |
| X080-382819-08PC-STR | Height 19 mm | In distribution |
| X080-382819-12PC-STR | Length 28 mm | In distribution |
| X080-332613-08PC-STRX | Angle 8 ° | In distribution |
| X080-382811-08PC-STRX | Height 11 mm | In distribution |
| X080-423013-12-STR | Angle 12 ° | In distribution |
| X080-423015-20T-STR | 30mm depth X 20°, 15mm height | In distribution |
| X080-332615-20-STR | Width 33 mm | In distribution |
| X080-382817-24-STR | Width 38 mm | In distribution |
| X080-382819-20T-STR | 28mm depth X 20°, 19mm height | In distribution |
| X080-382813-08-STRX | Angle 8 ° | In distribution |
| X080-382811-12PC-STR | Width 38 mm | In distribution |
| X080-423011-12PC-STRX | Length 30 mm | In distribution |
| X080-382815-12-STR | Width 38 mm | In distribution |
| X080-332615-24T-STR | Width 33 mm | In distribution |
| X080-382815-08-STR | Angle 8 ° | In distribution |
| X080-423015-08PC-STR | Width 42 mm | In distribution |
| X080-382811-08PC-STR | Length 28 mm | In distribution |
| X080-332615-16T-STR | 26mm depth X 16°, 15mm height | In distribution |
| X080-5525ST | Length 25 mm | In distribution |
| X080-5525SDX | Length 25 mm | In distribution |
| X080-6025 | Length 25 mm | In distribution |
| X080-332611-08-STR | Length 26 mm | In distribution |
| X080-5530SD | Length 30 mm | In distribution |
| X080-423019-20PC-STR | Width 42 mm | In distribution |
| X080-382817-20T-STR | Width 38 mm | In distribution |
| X080-6025X | Outer Diameter 6 mm | In distribution |
| X080-332619-20PC-STR | 26mm depth X 20°, 19mm height | In distribution |
| X080-382813-12PC-STR | Length 28 mm | In distribution |
| X080-382817-12-STRX | Length 28 mm | In distribution |
| X080-332619-12PC-STRX | Angle 12 ° | In distribution |
| X080-423015-24T-STR | Width 42 mm | In distribution |
| X080-382819-16T-STR | 28mm depth X 16°, 19mm height | In distribution |
| X080-423013-08PC-STRX | Height 13 mm | In distribution |
| X080-423017-16PC-STR | Width 42 mm | In distribution |
| X080-423019-16PC-STR | 30mm depth X 16°, 19mm height | In distribution |
| X080-382817-16-STR | Width 38 mm | In distribution |
| X080-382815-08PC-STR | Angle 8 ° | In distribution |
| X080-332615-20T-STR | Width 33 mm | In distribution |
| X080-382811-12-STR | Length 28 mm | In distribution |
| X080-423017-24T-STR | 30mm depth X 24°, 17mm height | In distribution |
| X080-332619-24PC-STR | Width 33 mm | In distribution |
| X080-423017-12PC-STR | Height 17 mm | In distribution |
| X080-382817-12PC-STRX | Angle 12 ° | In distribution |
| X080-332617-24PC-STR | Width 33 mm | In distribution |
| X080-332611-16T-STR | Width 33 mm | In distribution |
| X080-382817-20PC-STR | 28mm depth X 20°, 17mm height | In distribution |
| X080-332619-16T-STR | Width 33 mm | In distribution |
| X080-332617-20T-STR | Width 33 mm | In distribution |
| X080-332619-12-STRX | Width 33 mm | In distribution |
| X080-382819-12-STRX | Height 19 mm | In distribution |
| X080-382815-12PC-STR | Width 38 mm | In distribution |
| X080-332613-08PC-STR | Height 13 mm | In distribution |
| X080-382819-12PC-STRX | Length 28 mm | In distribution |
| X080-6040X | Length 40 mm | In distribution |
| X080-423013-16T-STR | 30mm depth X 16°, 13mm height | In distribution |
| X080-332617-12-STRX | Angle 12 ° | In distribution |
| X080-332617-16T-STR | Width 33 mm | In distribution |
| X080-382819-24PC-STR | Width 38 mm | In distribution |
| X080-382817-08-STR | Width 38 mm | In distribution |
| X080-382815-24T-STR | Width 38 mm | In distribution |
| X080-423015-12-STRX | Angle 12 ° | In distribution |
| X080-382813-08PC-STRX | Height 13 mm | In distribution |
| X080-5535SD | Outer Diameter 5.5 mm | In distribution |
| X080-332613-24T-STR | 26mm depth X 24°, 13mm height | In distribution |
| X080-332617-24-STR | Width 33 mm | In distribution |
| X080-423011-12PC-STR | Height 11 mm | In distribution |
| X080-332619-12-STR | Length 26 mm | In distribution |
| X080-382815-20-STR | 28mm depth X 20°, 15mm height | In distribution |
| X080-382819-12-STR | Angle 12 ° | In distribution |
| X080-332619-16-STR | 26mm depth X 16°, 19mm height | In distribution |
| X080-332615-08PC-STRX | Length 26 mm | In distribution |
| X080-382813-08PC-STR | Width 38 mm | In distribution |
| X080-382817-16PC-STR | 28mm depth X 16°, 17mm height | In distribution |
| C080-0073 | In distribution | |
| X080-5530STX | Length 30 mm | In distribution |
| X080-5540SD | Outer Diameter 5.5 mm | In distribution |
| X080-423017-16-STR | Width 42 mm | In distribution |
| X080-332617-08-STRX | Angle 8 ° | In distribution |
| X080-423015-12PC-STR | Width 42 mm | In distribution |
| X080-332611-20T-STR | 26mm depth X 20°, 11mm height | In distribution |
| X080-382817-16T-STR | Width 38 mm | In distribution |
| X080-423015-16PC-STR | 30mm depth X 16°, 15mm height | In distribution |
| X080-332615-16PC-STR | Width 33 mm | In distribution |
| X080-423015-12-STR | Width 42 mm | In distribution |
| X080-332613-16PC-STR | Width 33 mm | In distribution |
| X080-423013-08-STRX | Length 30 mm | In distribution |
| X080-332619-16PC-STR | Width 33 mm | In distribution |
| X080-332613-12PC-STRX | Width 33 mm | In distribution |
| X080-382815-16T-STR | Width 38 mm | In distribution |
| X080-382817-24PC-STR | 28mm depth X 24°, 17mm height | In distribution |
| X080-423019-24T-STR | 30mm depth X 24°, 19mm height | In distribution |
| X080-332615-12PC-STRX | Length 26 mm | In distribution |
| X080-423019-12-STR | Width 42 mm | In distribution |
| X080-332617-08PC-STRX | Length 26 mm | In distribution |
| X080-382819-24T-STR | 28mm depth X 24°, 19mm height | In distribution |
| X080-382811-12PC-STRX | Length 28 mm | In distribution |
| X080-5540STX | Outer Diameter 5.5 mm | In distribution |
| X080-382817-08PC-STR | Width 38 mm | In distribution |
| X080-382817-24T-STR | Width 38 mm | In distribution |
| X080-332619-20-STR | Width 33 mm | In distribution |
| C080-0039 | In distribution | |
| X080-332619-08-STRX | Length 26 mm | In distribution |
| X080-5535ST | Length 35 mm | In distribution |
| X080-332619-08-STR | Height 19 mm | In distribution |
| X080-423019-12-STRX | Width 42 mm | In distribution |
| X080-382817-08PC-STRX | Height 17 mm | In distribution |
| X080-332613-08-STRX | Angle 8 ° | In distribution |
| X080-423011-08-STR | Length 30 mm | In distribution |
| X080-382813-12PC-STRX | Angle 12 ° | In distribution |
| X080-6035X | Length 35 mm | In distribution |
| X080-423019-08PC-STRX | Width 42 mm | In distribution |
| X080-423013-08-STR | Angle 8 ° | In distribution |
| X080-382819-20-STR | 28mm depth X 20°, 19mm height | In distribution |
| X080-382815-20T-STR | Width 38 mm | In distribution |
| X080-332613-20T-STR | 26mm depth X 20°, 13mm height | In distribution |
| X080-5530ST | Length 30 mm | In distribution |
| X080-423015-08-STR | Length 30 mm | In distribution |
| X080-332617-12PC-STRX | Angle 12 ° | In distribution |
| X080-332617-12-STR | Length 26 mm | In distribution |
| X080-423017-08PC-STRX | Length 30 mm | In distribution |
| X080-423019-24PC-STR | Width 42 mm | In distribution |
| X080-423011-08PC-STRX | Length 30 mm | In distribution |
| X080-332613-08-STR | Length 26 mm | In distribution |
| X080-6030X | Length 30 mm | In distribution |
| X080-423019-16-STR | Width 42 mm | In distribution |
| X080-332615-16-STR | Width 33 mm | In distribution |
| X080-382817-12PC-STR | Angle 12 ° | In distribution |
| X080-332611-08PC-STRX | Length 26 mm | In distribution |
| X080-332619-12PC-STR | Length 26 mm | In distribution |
| X080-382819-08PC-STRX | Length 28 mm | In distribution |
| X080-423017-08PC-STR | Width 42 mm | In distribution |
| X080-332617-20-STR | Width 33 mm | In distribution |
| X080-6030 | Outer Diameter 6 mm | In distribution |
| X080-423015-08PC-STRX | Height 15 mm | In distribution |
| X080-423019-20-STR | Width 42 mm | In distribution |
| X080-382819-24-STR | Width 38 mm | In distribution |
| X080-382811-08-STRX | Height 11 mm | In distribution |
| X080-382819-16-STR | Width 38 mm | In distribution |
| X080-423017-12-STR | Width 42 mm | In distribution |
| X080-423017-08-STR | Angle 8 ° | In distribution |
| X080-332615-08-STR | Angle 8 ° | In distribution |
| X080-332613-12-STRX | Width 33 mm | In distribution |
| X080-332615-08-STRX | Height 15 mm | In distribution |
| X080-332613-16-STR | 26mm depth X 16°, 13mm height | In distribution |
| X080-332617-08-STR | Width 33 mm | In distribution |
| X080-423017-20T-STR | Width 42 mm | In distribution |
| X080-382815-16-STR | 28mm depth X 16°, 15mm height | In distribution |
| X080-423011-08PC-STR | Length 30 mm | In distribution |
| X080-382815-12PC-STRX | Width 38 mm | In distribution |
| X080-332617-12PC-STR | Width 33 mm | In distribution |
| X080-332617-16PC-STR | 26mm depth X 16°, 17mm height | In distribution |
| X080-382813-08-STR | Angle 8 ° | In distribution |
| X080-6035 | Outer Diameter 6 mm | In distribution |
| X080-382817-20-STR | Width 38 mm | In distribution |
| X080-332617-20PC-STR | Width 33 mm | In distribution |
| X080-423019-24-STR | Width 42 mm | In distribution |
| X080-332615-12PC-STR | Width 33 mm | In distribution |
| X080-423017-16T-STR | 30mm depth X 16°, 17mm height | In distribution |
| X080-423019-20T-STR | 30mm depth X 20°, 19mm height | In distribution |
| X080-332619-08PC-STRX | Angle 8 ° | In distribution |
| X080-332617-08PC-STR | Angle 8 ° | In distribution |
| X080-5540SDX | Length 40 mm | In distribution |
| X080-6040 | Length 40 mm | In distribution |
| X080-382811-16T-STR | Width 38 mm | In distribution |
| X080-423017-08-STRX | Length 30 mm | In distribution |
| X080-423019-12PC-STR | Angle 12 ° | In distribution |
| X080-5525STX | Length 25 mm | In distribution |
| X080-423019-16T-STR | 30mm depth X 16°, 19mm height | In distribution |
| X080-332615-12-STRX | Angle 12 ° | In distribution |
| X080-382815-16PC-STR | 28mm depth X 16°, 15mm height | In distribution |
| X080-382813-16PC-STR | 28mm depth X 16°, 13mm height | In distribution |
| X080-332611-08PC-STR | Width 33 mm | In distribution |
| X080-423019-08-STRX | Length 30 mm | In distribution |
| X080-332615-20PC-STR | 26mm depth X 20°, 15mm height | In distribution |
| X080-423011-08-STRX | Height 11 mm | In distribution |
| X080-382815-12-STRX | Length 28 mm | In distribution |
| X080-423017-12-STRX | Width 42 mm | In distribution |
| X080-423015-12PC-STRX | Height 15 mm | In distribution |
| X080-423015-08-STRX | Width 42 mm | In distribution |
| X080-382813-16-STR | Width 38 mm | In distribution |
| X080-382811-08-STR | Length 28 mm | In distribution |
| X080-423015-16-STR | Width 42 mm | In distribution |
| X080-423019-08PC-STR | Length 30 mm | In distribution |
| X080-382813-12-STRX | Angle 12 ° | In distribution |
| X080-332611-08-STRX | Height 11 mm | In distribution |
| X080-423011-16T-STR | Width 42 mm | In distribution |
| X080-332619-20T-STR | 26mm depth X 20°, 19mm height | In distribution |
| X080-382813-20T-STR | 28mm depth X 20°, 13mm height | In distribution |
| X080-423017-12PC-STRX | Angle 12 ° | In distribution |
| X080-332617-24T-STR | 26mm depth X 24°, 17mm height | In distribution |
| X080-423015-16T-STR | Width 42 mm | In distribution |
| X080-332615-12-STR | Length 26 mm | In distribution |
| X080-332613-16T-STR | Width 33 mm | In distribution |
| X080-382819-16PC-STR | Width 38 mm | In distribution |
| X080-382811-12-STRX | Height 11 mm | In distribution |
| X080-332611-12PC-STR | Angle 12 ° | In distribution |
| X080-423019-12PC-STRX | Angle 12 ° | In distribution |
| X080-423019-08-STR | Height 19 mm | In distribution |
| X080-382819-20PC-STR | 28mm depth X 20°, 19mm height | In distribution |
| X080-423011-12-STRX | Height 11 mm | In distribution |
| X080-423017-20PC-STR | 30mm depth X 20°, 17mm height | In distribution |
| X080-332617-16-STR | 26mm depth X 16°, 17mm height | In distribution |
| X080-423013-12PC-STRX | Length 30 mm | In distribution |
| X080-332611-12PC-STRX | Width 33 mm | In distribution |
| X080-423017-20-STR | 30mm depth X 20°, 17mm height | In distribution |
| X080-5540ST | Length 40 mm | In distribution |
| X080-332619-24T-STR | Width 33 mm | In distribution |
| X080-332611-12-STRX | Angle 12 ° | In distribution |
| X080-382813-12-STR | Height 13 mm | In distribution |
| X080-382813-16T-STR | Width 38 mm | In distribution |
| X080-332613-12-STR | Angle 12 ° | In distribution |
| X080-423013-08PC-STR | Length 30 mm | In distribution |
| X080-5525SD | Length 25 mm | In distribution |
| X080-423013-20T-STR | 30mm depth X 20°, 13mm height | In distribution |
| X080-423011-12-STR | Angle 12 ° | In distribution |
| X080-423013-12PC-STR | Angle 12 ° | In distribution |
| X080-5530SDX | Outer Diameter 5.5 mm | In distribution |
| X080-382815-08PC-STRX | Angle 8 ° | In distribution |
| X080-382817-12-STR | Angle 12 ° | In distribution |
| X080-332611-12-STR | Height 11 mm | In distribution |
| X080-332619-24-STR | 26mm depth X 24°, 19mm height | In distribution |
| X080-332613-12PC-STR | Angle 12 ° | In distribution |
| X080-382815-08-STRX | Length 28 mm | In distribution |
| X080-332615-08PC-STR | Length 26 mm | In distribution |
| X080-382819-08-STR | Angle 8 ° | In distribution |
| X080-332615-08T | Angle 8 ° | Withdrawn |
| X080-332611-08TX | Angle 8 ° | Withdrawn |
| X080-332617-12T | Height 17 mm | Withdrawn |
| X080-332617-12TX | Length 26 mm | Withdrawn |
| X080-332615-08TX | Width 33 mm | Withdrawn |
| X080-332613-12TPC | Angle 12 ° | Withdrawn |
| X080-423015-08TPC | Length 30 mm | Withdrawn |
| X080-332619-12T | Width 33 mm | Withdrawn |
| X080-382813-12T | Width 38 mm | Withdrawn |
| X080-332617-12TPC | Width 33 mm | Withdrawn |
| X080-332619-12TPCX | Angle 12 ° | Withdrawn |
| X080-382813-08TPC | Angle 8 ° | Withdrawn |
| X080-332611-12TX | Length 26 mm | Withdrawn |
| X080-332613-12TX | Width 33 mm | Withdrawn |
| X080-423019-12T | Width 42 mm | Withdrawn |
| X080-332617-08T | Height 17 mm | Withdrawn |
| X080-423019-08T | Angle 8 ° | Withdrawn |
| X080-423011-08T | Height 11 mm | Withdrawn |
Showing 250 of 300 catalogue numbers.
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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Xtant Medical Holdings, Inc. | UDI-DI | 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.