Novo Surgical
zenith bone file #92a, single-ended, 2.0 mm wide, file outside, backward cutting, angled w/ serrations, 6" (15.0 cm)
9manufacturers in China registered for this device type
15catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Shandong (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Novo Surgical, Inc., United States |
|---|---|
| FDA product code | HTP |
| Device type | File |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N98831-13 | In distribution | |
| N98831-19 | In distribution | |
| N93725-39 | In distribution | |
| N98831-12 | In distribution | |
| N8831-15 | In distribution | |
| N93724-61 | In distribution | |
| N98831-18 | In distribution | |
| D95464-87 | In distribution | |
| N98831-22 | In distribution | |
| N98831-10 | In distribution | |
| N98831-15 | In distribution | |
| N98831-21 | In distribution | |
| N93721-22 | In distribution | |
| N93721-24 | In distribution | |
| N93721-25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Acetabular bone rasp | Xinhua Healthcare Industry Co., Limited | 36 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 16 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 8 |
| TaperSet Hip System | Shalby Advanced Technologies, Inc. | 6 |
| Rasp Up Bend 20° | T.A.G Medical Products Agricultural Cooperative Association | 6 |
| Rasp Down Bend 20° | T.A.G Medical Products Agricultural Cooperative Association | 6 |
| gSource | Gsource, LLC. | 5 |
| Aesculap | Aesculap AG | 5 |
| Kmedic | Teleflex Medical LLC | 4 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 4 |
| Ambler Surgical | Ambler Surgical, LLC | 4 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 3 |
Showing 12 of 38. All products under File
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.