Apollo
Apollo Medial Suture Anchor Delivery System, Titanium Screw, 6.5 x 15mm, Two #2 ForceBraid™ Sutures
7manufacturers in China registered for this device type
53catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Renolit Hansen Packaging Tech. (BJ) Ltd. | Beijing | Beijing | Contract manufacturer | 1 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Zhejiang Decans Medical Devices Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| 510(k) | K142230 |
| Record published | 2017-08-17 |
| Record revised | 2024-09-30 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 5, pack of 5 |
| Sizes | Length 15 mm; outer diameter 4.5 to 6.5 mm |
| Distribution end date | 2024-11-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LA-4520-TI | In distribution | |
| 31-14520-TI | In distribution | |
| MSA-5515 | In distribution | |
| 31-15520 | In distribution | |
| XTS-6515 | In distribution | |
| LA-6520-TI | In distribution | |
| LA-6520 | In distribution | |
| 01 | In distribution | |
| 31-16520 | In distribution | |
| 41-15520 | In distribution | |
| MSA-5515-TI | In distribution | |
| LA-5520-TI | In distribution | |
| 01 | Length 15 mm | In distribution |
| MSA-4515-TI | In distribution | |
| 41-14520 | In distribution | |
| 31-16520-TI | In distribution | |
| MSA-6515 | In distribution | |
| 01 | In distribution | |
| 31-15520-TI | In distribution | |
| MSA-6515-TI | In distribution | |
| 01 | In distribution | |
| 27-11165 | Outer Diameter 6.5 mm | In distribution |
| 31-15520S | In distribution | |
| MSA-4515 | In distribution | |
| 01 | In distribution | |
| 27-11155 | Outer Diameter 5.5 mm | In distribution |
| LA-5520 | In distribution | |
| XTS-5515-TI | In distribution | |
| 27-11165 | In distribution | |
| 27-11155 | In distribution | |
| 01 | In distribution | |
| 41-16520 | In distribution | |
| XTS-5515 | In distribution | |
| 41-15520-TI | In distribution | |
| 27-11145 | In distribution | |
| 41-16520-TI | In distribution | |
| LA-4520 | In distribution | |
| 41-14520-TI | In distribution | |
| 31-14520S | In distribution | |
| 31-14520 | In distribution | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 30-16515 | Withdrawn | |
| 30-15515 | Withdrawn | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 01 | Withdrawn | |
| 30-14515 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 362 |
| HNM Sports Medicine | HNM Stainless, LLC. | 150 |
| Suture Anchors – HTA Headless Titanium Anchor and Zip Anchors | GM DOS Reis Industria E Comercio Ltda | 78 |
| Juggerknot® | Biomet Orthopedics | 77 |
| Fastener, Fixation, Nondegradable, Soft Tissue | Parcus Medical, LLC | 74 |
| endophix | Suzhou Endophix Co., Ltd. | 71 |
| Titan | Medline Industries, Inc. | 68 |
| TopLock | Fusion Orthopedics, LLC | 67 |
| HNM Medical | HNM Stainless, LLC. | 59 |
| Orthobutton CL | Riverpoint Medical LLC | 55 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
| Twinfix | Smith & Nephew, Inc. | 45 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Valeris Medical | 510(k) number | 2018-01-22 | Class II | Process control | The label on Apollo XT 5.5mm Suture Anchor (part # XTS-5515; lots 2358, 2362, and 2363) indicated that the anchor screw material was titanium, however that part number is made of PEEK. | 113 units | 2021-04-09 |
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.