ROI-A
ROI-A Starter AWL Support FOR M Anchoring Plate
3manufacturers in China registered for this device type
552catalogue 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 2 to 14 °; height 9 to 19 mm; depth 23 to 39 mm; width 26 to 42 mm; weight 30 to 33 mg; depth 30 µm |
| Distribution end date | 2016-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IR9388R | Angle 6 ° | In distribution |
| IR2616P | Angle 2 ° | In distribution |
| IR8314R | Depth 33 mm | In distribution |
| IR9385R | Depth 33 mm | In distribution |
| IR8207R | Depth 23 mm | In distribution |
| IR5241P | Angle 14 ° | In distribution |
| IR4339P | Angle 10 ° | In distribution |
| IR5141P | Angle 14 ° | In distribution |
| IR4417P | Angle 2 ° | In distribution |
| IR5410P | Angle 2 ° | In distribution |
| IR9318R | Angle 2 ° | In distribution |
| IR8264R | Depth 27 mm | In distribution |
| IR5124P | Angle 6 ° | In distribution |
| IR5333P | Angle 10 ° | In distribution |
| IR2613P | Angle 2 ° | In distribution |
| IR5123P | Angle 6 ° | In distribution |
| IR9372R | Angle 14 ° | In distribution |
| IR5135P | Angle 10 ° | In distribution |
| IR5312P | Angle 2 ° | In distribution |
| IR8223R | Angle 10 ° | In distribution |
| IR9359R | Depth 30 mm | In distribution |
| IR2412P | Angle 2 ° | In distribution |
| IR9307R | Angle 14 ° | In distribution |
| IR5129P | Angle 6 ° | In distribution |
| IR92003R | In distribution | |
| IR8272R | Depth 30 mm | In distribution |
| IR5116P | Angle 2 ° | In distribution |
| IR9322R | Angle 2 ° | In distribution |
| IR9327R | Depth 27 mm | In distribution |
| IR92000R-S | In distribution | |
| IR4325P | Angle 6 ° | In distribution |
| IR4233P | Angle 10 ° | In distribution |
| IR2745P | Angle 14 ° | In distribution |
| IR9364R | Angle 10 ° | In distribution |
| IR4332P | Angle 10 ° | In distribution |
| IR9335R | Depth 27 mm | In distribution |
| IR8237R | Angle 2 ° | In distribution |
| IR8326R | Depth 33 mm | In distribution |
| IR5321P | Angle 6 ° | In distribution |
| SI-ROIA-0025 | In distribution | |
| IR8230R | Depth 23 mm | In distribution |
| IR8220R | Depth 23 mm | In distribution |
| IR9321R | Depth 27 mm | In distribution |
| IR8246R | Depth 27 mm | In distribution |
| IR8221R | Angle 10 ° | In distribution |
| IR8242R | Depth 27 mm | In distribution |
| IR8249R | Angle 6 ° | In distribution |
| SI-ROIA-0015 | In distribution | |
| IR8283R | Angle 6 ° | In distribution |
| IR8202R | Angle 2 ° | In distribution |
| IR4314P | Angle 2 ° | In distribution |
| IR5144P | Angle 14 ° | In distribution |
| IR5343P | Angle 14 ° | In distribution |
| IR2637P | Angle 10 ° | In distribution |
| IR5145P | Angle 14 ° | In distribution |
| IR8247R | Angle 6 ° | In distribution |
| IR2533P | Angle 10 ° | In distribution |
| IR5342P | Angle 14 ° | In distribution |
| IR2544P | Angle 14 ° | In distribution |
| IR2736P | Angle 10 ° | In distribution |
| IR4413P | Angle 2 ° | In distribution |
| IR5237P | Angle 10 ° | In distribution |
| IR9290R | Depth 23 mm | In distribution |
| IR5211P | Angle 2 ° | In distribution |
| IR4225P | Angle 6 ° | In distribution |
| IR9339R | Depth 27 mm | In distribution |
| IR5246P | Angle 14 ° | In distribution |
| IR9395R | Depth 33 mm | In distribution |
| IR8269R | Angle 14 ° | In distribution |
| IR5210P | Angle 2 ° | In distribution |
| IR5338P | Angle 10 ° | In distribution |
| IR8241R | Angle 2 ° | In distribution |
| IR8316R | Depth 33 mm | In distribution |
| IR9295R | Angle 6 ° | In distribution |
| IR8212R | Depth 23 mm | In distribution |
| IR4235P | Angle 10 ° | In distribution |
| IR9397R | Depth 33 mm | In distribution |
| IR5345P | Angle 14 ° | In distribution |
| IR2526P | Angle 6 ° | In distribution |
| IR9358R | Angle 6 ° | In distribution |
| IR5413P | Angle 2 ° | In distribution |
| IR8238R | Depth 27 mm | In distribution |
| IR8261R | Angle 10 ° | In distribution |
| IR4246P | Angle 14 ° | In distribution |
| IR5137P | Angle 10 ° | In distribution |
| IR5416P | Angle 2 ° | In distribution |
| IR4324P | Angle 6 ° | In distribution |
| IR5231P | Angle 10 ° | In distribution |
| IR5220P | Angle 6 ° | In distribution |
| IR2546P | Angle 14 ° | In distribution |
| IR5119P | Angle 2 ° | In distribution |
| IR5122P | Angle 6 ° | In distribution |
| IR9368R | Angle 10 ° | In distribution |
| IR4237P | Angle 10 ° | In distribution |
| SI-ROIA-0040 | In distribution | |
| IR4241P | Angle 14 ° | In distribution |
| IR5319P | Angle 2 ° | In distribution |
| IR8250R | Depth 27 mm | In distribution |
| IR8311R | Angle 2 ° | In distribution |
| IR8303R | Angle 14 ° | In distribution |
| IR4333P | Angle 10 ° | In distribution |
| IR5419P | Angle 2 ° | In distribution |
| IR9353R | Depth 30 mm | In distribution |
| IR9378R | Angle 2 ° | In distribution |
| IR2414P | Angle 2 ° | In distribution |
| IR8262R | Depth 27 mm | In distribution |
| IR9394R | Angle 10 ° | In distribution |
| IR9330R | Angle 6 ° | In distribution |
| IR8259R | Angle 10 ° | In distribution |
| IR9365R | Depth 30 mm | In distribution |
| IR8204R | Angle 2 ° | In distribution |
| IR9402R | Angle 14 ° | In distribution |
| IR8208R | Angle 2 ° | In distribution |
| IR8297R | Angle 10 ° | In distribution |
| IR5131P | Angle 10 ° | In distribution |
| IR8260R | Depth 27 mm | In distribution |
| IR8252R | Depth 27 mm | In distribution |
| IR8232R | Depth 23 mm | In distribution |
| IR2537P | Angle 10 ° | In distribution |
| IR2642P | Angle 14 ° | In distribution |
| IR9347R | Depth 30 mm | In distribution |
| IR8325R | Angle 10 ° | In distribution |
| IR8206R | Angle 2 ° | In distribution |
| IR5332P | Angle 10 ° | In distribution |
| IR5325P | Angle 6 ° | In distribution |
| IR8256R | Depth 27 mm | In distribution |
| IR9288R | In distribution | |
| SI-ROIA-0009 | In distribution | |
| IR9354R | Angle 6 ° | In distribution |
| IR8258R | Depth 27 mm | In distribution |
| IR4232P | Angle 10 ° | In distribution |
| IR8275R | Angle 2 ° | In distribution |
| IR9360R | Angle 6 ° | In distribution |
| IR5128P | Angle 6 ° | In distribution |
| IR2744P | Angle 14 ° | In distribution |
| IR9350R | Angle 2 ° | In distribution |
| IR4427P | Angle 6 ° | In distribution |
| IR5147P | Angle 14 ° | In distribution |
| IR9280R | In distribution | |
| IR4316P | Angle 2 ° | In distribution |
| IR9381R | Depth 33 mm | In distribution |
| IR4444P | Angle 14 ° | In distribution |
| IR5115P | Angle 2 ° | In distribution |
| IR8235R | Angle 14 ° | In distribution |
| IR4428P | Angle 6 ° | In distribution |
| IR8305R | Angle 14 ° | In distribution |
| IR5328P | Angle 6 ° | In distribution |
| IR2635P | Angle 10 ° | In distribution |
| IR4222P | Angle 6 ° | In distribution |
| IR5134P | Angle 10 ° | In distribution |
| IR8244R | Depth 27 mm | In distribution |
| IR4446P | Angle 14 ° | In distribution |
| IR9331R | Depth 27 mm | In distribution |
| IR5311P | Angle 2 ° | In distribution |
| IR8292R | Depth 30 mm | In distribution |
| IR4436P | Angle 10 ° | In distribution |
| IR4341P | Angle 14 ° | In distribution |
| IR5242P | Angle 14 ° | In distribution |
| IR8277R | Angle 2 ° | In distribution |
| IR9384R | Angle 6 ° | In distribution |
| IR9340R | Angle 14 ° | In distribution |
| IR8315R | Angle 2 ° | In distribution |
| IR4416P | Angle 2 ° | In distribution |
| IR2638P | Angle 10 ° | In distribution |
| IR4441P | Angle 14 ° | In distribution |
| IR4326P | Angle 2 ° | In distribution |
| SI-ROIA-0028 | In distribution | |
| IR4445P | Angle 14 ° | In distribution |
| IR2543P | Angle 14 ° | In distribution |
| IR8213R | Angle 6 ° | In distribution |
| IR8295R | Angle 10 ° | In distribution |
| IR5326P | Angle 6 ° | In distribution |
| IR9362R | Angle 10 ° | In distribution |
| IR2633P | Angle 10 ° | In distribution |
| IR4312P | Angle 2 ° | In distribution |
| IR4345P | Angle 14 ° | In distribution |
| IR9400R | Angle 14 ° | In distribution |
| IR4334P | Angle 10 ° | In distribution |
| IR9401R | Depth 33 mm | In distribution |
| IR5120P | Angle 6 ° | In distribution |
| IR5146P | Angle 14 ° | In distribution |
| IR9382R | Angle 2 ° | In distribution |
| IR9303R | Angle 10 ° | In distribution |
| IR8279R | Angle 2 ° | In distribution |
| IR4343P | Angle 14 ° | In distribution |
| IR4212P | Angle 2 ° | In distribution |
| IR5113P | Angle 2 ° | In distribution |
| IR4211P | Angle 2 ° | In distribution |
| IR5112P | Angle 2 ° | In distribution |
| IR9283R | In distribution | |
| IR8282R | Depth 30 mm | In distribution |
| SI-ROIA-0030 | In distribution | |
| IR8330R | Depth 33 mm | In distribution |
| IR2534P | Angle 10 ° | In distribution |
| IR8332R | Depth 33 mm | In distribution |
| IR4425P | Angle 6 ° | In distribution |
| IR5133P | Angle 10 ° | In distribution |
| IR5215P | Angle 2 ° | In distribution |
| IR5336P | Angle 10 ° | In distribution |
| IR2622P | Angle 6 ° | In distribution |
| IR4234P | Angle 10 ° | In distribution |
| IR2623P | Angle 6 ° | In distribution |
| IR2726P | Angle 6 ° | In distribution |
| IR2542P | Width 30 mm | In distribution |
| IR8236R | Depth 27 mm | In distribution |
| IR5247P | Angle 14 ° | In distribution |
| IR8271R | Angle 2 ° | In distribution |
| IR9342R | Angle 14 ° | In distribution |
| IR4438P | Angle 10 ° | In distribution |
| SI-ROIA-0027 | In distribution | |
| IR5125P | Angle 6 ° | In distribution |
| IR5314P | Angle 2 ° | In distribution |
| IR2627P | Angle 6 ° | In distribution |
| IR8231R | Angle 14 ° | In distribution |
| IR8263R | Angle 10 ° | In distribution |
| IR5238P | Angle 10 ° | In distribution |
| IR92004R | In distribution | |
| IR9383R | Depth 33 mm | In distribution |
| IR2722P | Angle 6 ° | In distribution |
| IR8334R | Depth 33 mm | In distribution |
| IR8254R | Depth 27 mm | In distribution |
| IR9291R | Angle 2 ° | In distribution |
| IR9363R | Depth 30 mm | In distribution |
| IR5412P | Angle 2 ° | In distribution |
| IR9390R | Angle 6 ° | In distribution |
| IR8209R | Depth 23 mm | In distribution |
| IR9373R | Depth 30 mm | In distribution |
| IR5417P | Angle 2 ° | In distribution |
| IR8203R | Depth 23 mm | In distribution |
| IR2631P | Angle 10 ° | In distribution |
| IR5327P | Angle 6 ° | In distribution |
| IR2621P | Angle 6 ° | In distribution |
| IR9387R | Depth 33 mm | In distribution |
| IR5233P | Angle 10 ° | In distribution |
| IR9305R | Angle 14 ° | In distribution |
| IR8289R | Angle 6 ° | In distribution |
| IR5213P | Angle 2 ° | In distribution |
| IR9375R | Depth 30 mm | In distribution |
| IR9293R | Angle 2 ° | In distribution |
| IR2643P | Angle 14 ° | In distribution |
| IR4214P | Angle 2 ° | In distribution |
| IR5222P | Angle 6 ° | In distribution |
| IR2432P | Angle 10 ° | In distribution |
| IR8219R | Angle 6 ° | In distribution |
| IR8218R | Depth 23 mm | In distribution |
| IR9404R | Angle 14 ° | In distribution |
| IR8318R | Depth 33 mm | In distribution |
| SI-ROIA-0026 | In distribution | |
| IR4424P | Angle 6 ° | In distribution |
| IR5225P | Angle 6 ° | In distribution |
Showing 250 of 300 catalogue numbers.
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|---|---|---|
| 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 |
| 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 |
| 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.