Integra®
Integra® Drill w/Set Stop, for DA (2.7)
5manufacturers in China registered for this device type
47catalogue numbers in this listing
1510(k) clearance
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Shandong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Sinovation (Beijing) Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 1 |
Record
| Listed by | Integra Lifesciences Corporation, United States |
|---|---|
| FDA product code | HAW |
| Device type | Neurological Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K032054 |
| Record published | 2016-07-26 |
| Record revised | 2024-03-19 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Length 160 mm |
| Distribution end date | 2023-12-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RTNBND116 | In distribution | ||
| RT1876 | In distribution | ||
| RT11116 | In distribution | ||
| SR | In distribution | ||
| DA27 | In distribution | ||
| DA32 | In distribution | ||
| GT46116 | In distribution | ||
| RB32 | In distribution | ||
| RT2076 | In distribution | ||
| RB27 | In distribution | ||
| KDG | In distribution | ||
| HRW | In distribution | ||
| UCHREBA | In distribution | ||
| GT3276 | In distribution | ||
| SD27 | In distribution | ||
| SD32 | In distribution | ||
| GT32160 | In distribution | ||
| GT32116 | In distribution | ||
| DA27D | In distribution | ||
| TAP | In distribution | ||
| ASD1B | 10 | In distribution | |
| UCHRA | In distribution | ||
| RT20116 | In distribution | ||
| RT1176 | In distribution | ||
| RTNBND160 | Length 160 mm | In distribution | |
| DA46D | In distribution | ||
| RT18116 | In distribution | ||
| DA32D | In distribution | ||
| UCHRAP | In distribution | ||
| DA46 | In distribution | ||
| GT27116 | In distribution | ||
| HRD | In distribution | ||
| RT21116 | In distribution | ||
| GT27160 | In distribution | ||
| GT2776 | In distribution | ||
| RT16116 | In distribution | ||
| HRP | In distribution | ||
| UCHRHK | In distribution | ||
| RT2176 | In distribution | ||
| RT1676 | In distribution | ||
| RTNBND76 | In distribution | ||
| UCHRHK | In distribution | ||
| UCHRCASE | Withdrawn | ||
| UCHRPA | Withdrawn | ||
| SWTS | Withdrawn | ||
| UCHRPP | Withdrawn | ||
| RLPPSP | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neurological Stereotaxic Instrument | Medtronic Navigation, Inc. | 844 |
| PMT Corporation – Stereotactic | PMT Corp. | 255 |
| Leksell Stereotactic System | Elekta Instrument AB | 199 |
| Neurological Stereotaxic Instrument | Inomed Medizintechnik Gmbh | 146 |
| Neurological Stereotaxic Instrument | Stryker Leibinger Gmbh & Co. KG | 125 |
| Geniant Cranial | KOH Young Technology Inc. | 113 |
| CRW® | Integra Lifesciences Corporation | 107 |
| Leksell Stereotactic System | Elekta Solutions AB | 93 |
| microTargeting™ Insertion Tube with Stylet | FHC, Inc. | 60 |
| Leksell Stereotactic System Neurosurgical Instruments | Elekta Instrument AB | 58 |
| Leksell Vantage Stereotactic System | Elekta Instrument AB | 53 |
| Stealth Autoguide™ System | Medtronic Navigation, Inc. | 50 |
Showing 12 of 1,137. All products under Neurological Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K160811 | 2016-12-06 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2015-08-21 | Class II | Process design | Integra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing. | 6 units | 2016-10-13 |
| Integra Lifesciences Corporation | 510(k) number | 2012-08-09 | Class II | Device Design | T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical p | 175 units | 2014-03-26 |
| Integra Lifesciences Corporation | 510(k) number | 2012-08-09 | Class II | Device Design | T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical p | 188 units | 2014-03-26 |
| Integra Lifesciences Corporation | 510(k) number | 2011-01-12 | Not classified | Manufacturing material removal | Overall length of the intubation hoop in the HRAIM Intubation Head Ring Assembly is too long and will not allow a device to to attach | 8 units | 2011-04-04 |
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.