Surtex
FiberGrip Mallet Plane (Nylon) - Convex (Stainless Steel) 26.5 cm - 10 1/2" Head Ø 30.0 mm - Weight 675 Grams Stainless Steel
3manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Surtex Instruments Ltd, United Kingdom |
|---|---|
| FDA product code | GFJ |
| Device type | Mallet, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Remanufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-12 |
Specifications
| MRI safety | MR Conditional |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OR-478-90 | In distribution | |
| OR-472-24 | In distribution | |
| OR-480-18 | In distribution | |
| OR-504-19 | In distribution | |
| OR-488-02 | In distribution | |
| OR-504-90 | In distribution | |
| OR-450-02 | In distribution | |
| OR-500-18 | In distribution | |
| OR-462-01 | In distribution | |
| OR-502-01 | In distribution | |
| OR-476-16 | In distribution | |
| OR-502-02 | In distribution | |
| OR-474-20 | In distribution | |
| OR-464-24 | In distribution | |
| OR-458-21 | In distribution | |
| OR-450-03 | In distribution | |
| OR-474-18 | In distribution | |
| OR-452-02 | In distribution | |
| OR-452-03 | In distribution | |
| OR-494-24 | In distribution | |
| OR-492-29 | In distribution | |
| OR-450-01 | In distribution | |
| OR-470-19 | In distribution | |
| OR-468-24 | In distribution | |
| OR-466-24 | In distribution | |
| OR-460-17 | In distribution | |
| OR-490-26 | In distribution | |
| OR-478-19 | In distribution | |
| OR-462-02 | In distribution | |
| OR-488-01 | In distribution | |
| OR-486-22 | In distribution | |
| OR-454-20 | In distribution | |
| OR-498-90 | In distribution | |
| OR-452-01 | In distribution | |
| OR-496-24 | In distribution | |
| OR-498-22 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 86 |
| Millennium | Avalign Technologies, Inc. | 67 |
| gSource | Gsource, LLC. | 62 |
| Boss Instruments | Boss Instruments, Ltd. | 43 |
| Ambler Surgical | Ambler Surgical, LLC | 39 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 30 |
| Orthomed | Ortho-MED, Inc. | 28 |
| HNM Medical | HNM Stainless, LLC. | 26 |
| Kmedic | Teleflex Medical LLC | 23 |
| Avalign | Avalign Technologies, Inc. | 23 |
| V. Mueller | Steris Corporation | 22 |
| Mallet | KLS-Martin L.P. | 19 |
Showing 12 of 91. All products under Mallet, Surgical, General & Plastic Surgery
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.