Novo Surgical Inc.
zenith bone hook, sharp, stainless steel t-handle, 7" (18.0 cm)
3manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (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 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | KIK |
| Device type | Hook, Bone |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-11-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N8821-52 | In distribution | |
| N8821-30 | In distribution | |
| N8821-31 | In distribution | |
| N8821-43 | In distribution | |
| N8821-41 | In distribution | |
| N98821-43 | In distribution | |
| N8821-39 | In distribution | |
| E8821-21 | In distribution | |
| N8821-55 | In distribution | |
| N8821-51 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HNM Medical | HNM Stainless, LLC. | 65 |
| Millennium | Avalign Technologies, Inc. | 34 |
| Innomed, Inc. | Innomed, Inc. | 18 |
| gSource | Gsource, LLC. | 18 |
| Avalign | Avalign Technologies, Inc. | 14 |
| General Instrument | Orthopediatrics, Corp | 13 |
| Boss Instruments | Boss Instruments, Ltd. | 13 |
| Orthomed | Ortho-MED, Inc. | 13 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| Kmedic | Teleflex Medical LLC | 8 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 8 |
Showing 12 of 54. All products under Hook, Bone
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.