GMReis Suture Anchors
28 catalogue numbers from FASTLOCK - KNOTLESS PEEK ANCHOR Ø3.5x4.0, listed by GM DOS Reis Industria E Comercio Ltda, Brazil, under Fastener, Fixation, Nondegradable, Soft Tissue. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
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 | GM DOS Reis Industria E Comercio Ltda, Brazil |
|---|---|
| FDA product code | MBI |
| Device type | Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2025-12-09 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø3.5×4.0/8.5mm WITH OPEN EYELET AND 2.0mm WHITE/ | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø5.5×15.0mm | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø5.5×15.0/19.1mm WITH CLOSED EYELET | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø4.0×10.0mm | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø8.0×23.0mm WITH OPEN EY | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø3.5×10.1/15.8mm WITH CLOSED EYELET AND WHITE/BL | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø3.5×10.1/15.8mm WITH CLOSED EYELET AND WHITE/BL | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø4.75×15.0mm | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø4.0×10.0mm | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø5.5×15.0/19.1mm WITH CLOSED EYELET AND WHITE/BL | In distribution | |
| PRESSLOCK – IMPACTED KNOTLESS PEEK ANCHOR Ø2.5×4.7/8.0mm WITH CLOSED EYELET | In distribution | |
| PRESSLOCK LONG – IMPACTED KNOTLESS PEEK ANCHOR Ø2.9×10.5/15.5mm WITH CLOSED EYEL | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø3.0×8.0mm | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø5.5×15.0/19.1mm WITH CLOSED EYELET AND WHITE/BL | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø2.5×6.0mm | In distribution | |
| PRESSLOCK – IMPACTED KNOTLESS PEEK ANCHOR Ø2.9×7.5/12.5mm WITH CLOSED EYELET | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø3.5×4.0/8.5mm WITH OPEN EYELET AND 2.0mm WHITE/ | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø4.75×15.0/19.1mm WITH CLOSED EYELET | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø7.0×10.0mm | In distribution | |
| TENOLOCK – TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø6.25×15.0mm | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø4.75×15.0/19.1mm WITH CLOSED EYELET | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø3.5×10.1/15.8mm WITH CLOSED EYELET | In distribution | |
| TENOLOCK TENODESIS KNOTLESS PEEK ANCHOR WITH INSERTER Ø7.0×23.0mm WITH OPEN EYEL | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø4.75×15.0/19.1mm WITH CLOSED EYELET AND WHITE/B | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø4.75×15.0/19.1mm WITH CLOSED EYELET AND WHITE/B | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø2.5×3.6/7.0mm WITH OPEN EYELET | In distribution | |
| FASTLOCK – KNOTLESS PEEK ANCHOR Ø3.5×4.0/8.5mm WITH OPEN EYELET | In distribution | |
| PRESSLOCK – IMPACTED KNOTLESS PEEK ANCHOR Ø2.9×10.5/15.5mm WITH CLOSED EYELET | In distribution |
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 |
| Apollo | Medline Industries, Inc. | 53 |
| JuggerKnot Soft Anchor | Riverpoint Medical LLC | 46 |
Showing 12 of 618. All products under Fastener, Fixation, Nondegradable, Soft Tissue
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252664 | 2025-11-04 |
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.