Avenue L
Angled Avenue L inserter flexible inner threaded rod
3manufacturers in China registered for this device type
524catalogue numbers in this listing
4510(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 | Ldr Spine USA, United States |
|---|---|
| FDA product code | OVD |
| Device type | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3080 |
| Record published | 2017-03-23 |
| Record revised | 2025-01-03 (version 11) |
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 | Angle 0 to 14 °; width 17 to 60 mm; height 8 to 22 mm; depth 17 to 22 mm; depth 17 µm; height 16 µm; length 60 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SI-AVEL-0095 | Width 22 mm | In distribution |
| IR90043R | Angle 6 ° | In distribution |
| IR90082R | Angle 10 ° | In distribution |
| SI-AVEL-0040 | Width 22 mm | In distribution |
| IR6428P | Angle 6 ° | In distribution |
| IR90137R | Angle 10 ° | In distribution |
| SI-AVEL-0029 | Width 17 mm | In distribution |
| IR90233R | Width 55 mm | In distribution |
| IR90460R | Angle 0 ° | In distribution |
| IR6532P | Angle 6 ° | In distribution |
| IR90118R | Width 40 mm | In distribution |
| IR90058R | Angle 10 ° | In distribution |
| IR6908P | Angle 0 ° | In distribution |
| SI-AVEL-0116 | Angle 6 ° | In distribution |
| IR90488R | Width 22 mm | In distribution |
| IR6470P | Angle 14 ° | In distribution |
| IR6832P | Angle 6 ° | In distribution |
| IR6268P | Angle 14 ° | In distribution |
| IR90127R | Angle 0 ° | In distribution |
| IR90203R | Angle 10 ° | In distribution |
| IR90482R | Angle 0 ° | In distribution |
| IR90052R | Angle 6 ° | In distribution |
| IR90181R | Angle 10 ° | In distribution |
| IR90238R | Angle 10 ° | In distribution |
| SI-AVEL-0117 | Angle 0 ° | In distribution |
| IR90128R | Width 50 mm | In distribution |
| SI-AVEL-0144 | Angle 10 ° | In distribution |
| IR90173R | Angle 0 ° | In distribution |
| IR90241R | Angle 10 ° | In distribution |
| IR90511R | In distribution | |
| IR6256P | Angle 10 ° | In distribution |
| IR90126R | Angle 14 ° | In distribution |
| IR90080R | Width 55 mm | In distribution |
| IR90078R | Width 55 mm | In distribution |
| IR6450P | Angle 10 ° | In distribution |
| IR90106R | Angle 14 ° | In distribution |
| IR90256R | Width 60 mm | In distribution |
| IR90165R | Angle 10 ° | In distribution |
| IR90064R | Width 50 mm | In distribution |
| IR7234P | Angle 6 ° | In distribution |
| IR90262R | Width 60 mm | In distribution |
| IR90252R | Width 60 mm | In distribution |
| IR90183R | Angle 10 ° | In distribution |
| IR90141R | Width 55 mm | In distribution |
| IR6128P | Angle 6 ° | In distribution |
| SI-AVEL-0096 | Width 22 mm | In distribution |
| SI-AVEL-0108 | In distribution | |
| IR6348P | Angle 10 ° | In distribution |
| IR90033R | Width 35 mm | In distribution |
| IR90088R | Width 60 mm | In distribution |
| IR90196R | Width 45 mm | In distribution |
| SI-AVEL-0083 | Width 17 mm | In distribution |
| IR90114R | Angle 14 ° | In distribution |
| IR6368P | Angle 14 ° | In distribution |
| IR90245R | Width 55 mm | In distribution |
| IR90512R | In distribution | |
| IR90138R | Angle 14 ° | In distribution |
| SI-AVEL-0081 | Width 17 mm | In distribution |
| IR90090R | Angle 6 ° | In distribution |
| IR90053R | Width 45 mm | In distribution |
| IR7016P | Angle 0 ° | In distribution |
| IR7034P | Angle 6 ° | In distribution |
| IR90122R | Width 45 mm | In distribution |
| SI-AVEL-0043 | Angle 6 ° | In distribution |
| SI-AVEL-0045 | Width 22 mm | In distribution |
| SI-AVEL-0084 | Angle 6 ° | In distribution |
| IR90119R | Width 45 mm | In distribution |
| IR90251R | Angle 6 ° | In distribution |
| IR90155R | Angle 0 ° | In distribution |
| IR90483R | Angle 6 ° | In distribution |
| IR90228R | Angle 0 ° | In distribution |
| IR6854P | Angle 10 ° | In distribution |
| IR90158R | Width 35 mm | In distribution |
| SI-AVEL-0047 | Angle 6 ° | In distribution |
| IR90123R | Width 45 mm | In distribution |
| IR90465R | Width 17 mm | In distribution |
| IR6936P | Angle 6 ° | In distribution |
| IR6608P | Angle 0 ° | In distribution |
| IR90247R | Angle 0 ° | In distribution |
| IR90026R | Width 35 mm | In distribution |
| IR6536P | Angle 6 ° | In distribution |
| IR6232P | Angle 6 ° | In distribution |
| IR90199R | Width 45 mm | In distribution |
| IR7071P | Angle 14 ° | In distribution |
| IR6408P | Angle 0 ° | In distribution |
| IR90113R | Angle 10 ° | In distribution |
| IR90502R | In distribution | |
| IR90210R | Angle 0 ° | In distribution |
| IR6356P | Angle 10 ° | In distribution |
| IR90136R | Angle 6 ° | In distribution |
| IR90231R | Angle 0 ° | In distribution |
| IR7112P | Angle 0 ° | In distribution |
| IR90147R | Width 60 mm | In distribution |
| SI-AVEL-0126 | Angle 6 ° | In distribution |
| SI-AVEL-0127 | Width 22 mm | In distribution |
| IR90068R | Angle 10 ° | In distribution |
| IR6836P | Angle 6 ° | In distribution |
| IR90249R | Angle 0 ° | In distribution |
| IR90107R | Width 35 mm | In distribution |
| IR90246R | Width 60 mm | In distribution |
| IR6228P | Angle 6 ° | In distribution |
| IR90505R-S | In distribution | |
| IR90211R | Angle 0 ° | In distribution |
| IR90197R | Width 45 mm | In distribution |
| SI-AVEL-0088 | Angle 6 ° | In distribution |
| IR90178R | Width 40 mm | In distribution |
| IR90172R | Angle 0 ° | In distribution |
| IR6950P | Angle 10 ° | In distribution |
| IR90021R | In distribution | |
| SI-AVEL-0104 | In distribution | |
| IR90129R | Angle 10 ° | In distribution |
| IR90261R | Angle 14 ° | In distribution |
| IR90179R | Width 40 mm | In distribution |
| SI-AVEL-0028 | Angle 0 ° | In distribution |
| IR90209R | Angle 0 ° | In distribution |
| SI-AVEL-0097 | Angle 0 ° | In distribution |
| IR90208R | Width 50 mm | In distribution |
| IR6808P | Angle 0 ° | In distribution |
| IR90162R | Angle 10 ° | In distribution |
| IR90029R | Angle 6 ° | In distribution |
| IR6236P | Angle 6 ° | In distribution |
| IR6250P | Angle 10 ° | In distribution |
| IR90067R | Angle 6 ° | In distribution |
| IR6352P | Angle 10 ° | In distribution |
| IR90478R | Width 22 mm | In distribution |
| IR90201R | Angle 10 ° | In distribution |
| IR6850P | Angle 10 ° | In distribution |
| IR90185R | Angle 14 ° | In distribution |
| SI-AVEL-0109 | Width 17 mm | In distribution |
| IR90146R | Angle 14 ° | In distribution |
| IR90225R | Width 50 mm | In distribution |
| IR6132P | Angle 6 ° | In distribution |
| IR6812P | Angle 0 ° | In distribution |
| IR90222R | Angle 10 ° | In distribution |
| SI-AVEL-0079 | In distribution | |
| IR90031R | Angle 6 ° | In distribution |
| IR90046R | Width 40 mm | In distribution |
| IR90120R | Angle 6 ° | In distribution |
| IR90095R | Width 60 mm | In distribution |
| IR6414P | Angle 0 ° | In distribution |
| IR6330P | Angle 6 ° | In distribution |
| IR90124R | Angle 14 ° | In distribution |
| IR6948P | Angle 10 ° | In distribution |
| IR90170R | Width 40 mm | In distribution |
| SI-AVEL-0123 | Width 22 mm | In distribution |
| IR90257R | Angle 10 ° | In distribution |
| IR6154P | Angle 10 ° | In distribution |
| IR7210P | Angle 0 ° | In distribution |
| IR6828P | Angle 6 ° | In distribution |
| IR6112P | Angle 0 ° | In distribution |
| IR90487R | Width 22 mm | In distribution |
| IR90050R | Angle 0 ° | In distribution |
| IR7236P | Angle 6 ° | In distribution |
| IR6134P | Angle 6 ° | In distribution |
| IR6334P | Angle 6 ° | In distribution |
| SI-AVEL-0115 | Width 17 mm | In distribution |
| IR90145R | Angle 10 ° | In distribution |
| IR6614P | Angle 0 ° | In distribution |
| IR90494R | Angle 14 ° | In distribution |
| IR90194R | Angle 6 ° | In distribution |
| IR90495R | Angle 14 ° | In distribution |
| IR90168R | Width 35 mm | In distribution |
| IR6212P | Angle 0 ° | In distribution |
| IR6336P | Angle 6 ° | In distribution |
| SI-AVEL-0089 | Angle 0 ° | In distribution |
| IR7072P | Angle 14 ° | In distribution |
| IR90132R | Width 50 mm | In distribution |
| IR90218R | Width 50 mm | In distribution |
| SI-AVEL-0086 | Width 17 mm | In distribution |
| SI-AVEL-0092 | Angle 6 ° | In distribution |
| IR90184R | Angle 10 ° | In distribution |
| IR90133R | Width 50 mm | In distribution |
| SI-AVEL-0046 | Angle 0 ° | In distribution |
| IR6472P | Angle 14 ° | In distribution |
| IR90038R | Angle 0 ° | In distribution |
| IR6252P | Angle 10 ° | In distribution |
| IR7108P | Angle 0 ° | In distribution |
| IR90059R | Angle 10 ° | In distribution |
| IR90032R | Angle 10 ° | In distribution |
| IR90476R | Width 17 mm | In distribution |
| IR90030R | Angle 6 ° | In distribution |
| IR90149R | Width 60 mm | In distribution |
| IR6474P | Angle 14 ° | In distribution |
| IR6871P | Angle 14 ° | In distribution |
| IR6370P | Angle 14 ° | In distribution |
| IR90091R | Angle 6 ° | In distribution |
| IR6512P | Angle 0 ° | In distribution |
| IR90073R | Angle 0 ° | In distribution |
| IR90227R | Width 55 mm | In distribution |
| SI-AVEL-0119 | Angle 0 ° | In distribution |
| IR7116P | Angle 0 ° | In distribution |
| IR90464R | Angle 6 ° | In distribution |
| IR6932P | Angle 6 ° | In distribution |
| IR90063R | Width 50 mm | In distribution |
| IR6634P | Angle 6 ° | In distribution |
| IR6003T | In distribution | |
| IR6432P | Angle 6 ° | In distribution |
| IR90204R | Angle 14 ° | In distribution |
| SI-AVEL-0093 | Angle 0 ° | In distribution |
| IR90061R | Angle 10 ° | In distribution |
| IR90226R | Width 50 mm | In distribution |
| IR6456P | Angle 10 ° | In distribution |
| IR90232R | Angle 6 ° | In distribution |
| SI-AVEL-0121 | Angle 0 ° | In distribution |
| IR90242R | Angle 14 ° | In distribution |
| IR6002T | In distribution | |
| IR90192R | Angle 0 ° | In distribution |
| IR6852P | Angle 10 ° | In distribution |
| IR90475R | Width 17 mm | In distribution |
| IR6972P | Angle 14 ° | In distribution |
| IR90496R | Angle 14 ° | In distribution |
| IR90259R | Angle 10 ° | In distribution |
| IR90219R | Angle 10 ° | In distribution |
| IR90135R | Width 55 mm | In distribution |
| SI-AVEL-0034 | Angle 0 ° | In distribution |
| IR90134R | Width 50 mm | In distribution |
| IR90160R | Width 35 mm | In distribution |
| IR90260R | Angle 10 ° | In distribution |
| IR6550P | Angle 10 ° | In distribution |
| IR90054R | Width 45 mm | In distribution |
| IR6316P | Angle 0 ° | In distribution |
| IR7114P | Angle 0 ° | In distribution |
| IR6636P | Angle 6 ° | In distribution |
| IR90028R | Width 35 mm | In distribution |
| IR90255R | Width 60 mm | In distribution |
| IR7208P | Angle 0 ° | In distribution |
| IR6916P | Angle 0 ° | In distribution |
| IR7130P | Angle 6 ° | In distribution |
| IR90484R | Width 22 mm | In distribution |
| IR90148R | Width 60 mm | In distribution |
| IR90221R | Angle 10 ° | In distribution |
| SI-AVEL-0077 | In distribution | |
| IR6508P | Angle 0 ° | In distribution |
| IR90055R | Width 45 mm | In distribution |
| SI-AVEL-0091 | Angle 0 ° | In distribution |
| IR90034R | Width 35 mm | In distribution |
| SI-AVEL-0098 | Angle 6 ° | In distribution |
| IR6150P | Angle 10 ° | In distribution |
| IR90125R | Angle 14 ° | In distribution |
| SI-AVEL-0031 | Width 17 mm | In distribution |
| IR90490R | Angle 10 ° | In distribution |
| IR7054P | Width 50 mm | In distribution |
| SI-AVEL-0125 | Angle 0 ° | In distribution |
| IR90060R | Angle 0 ° | In distribution |
| IR90070R | Width 50 mm | In distribution |
| IR6928P | Angle 6 ° | In distribution |
| IR90105R | Angle 10 ° | In distribution |
| IR6374P | Angle 14 ° | In distribution |
| IR90189R | Width 45 mm | In distribution |
| IR6610P | Angle 0 ° | In distribution |
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 |
| 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 |
|---|---|
| K161173 | 2016-09-28 |
| K142645 | 2015-06-11 |
| K113285 | 2012-07-26 |
| K110327 | 2011-09-30 |
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.