Elan 4
Elan 4 MIS L13 Disp.diam.burr X-CRS D3.0
3manufacturers in China registered for this device type
529catalogue numbers in this listing
5510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (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 |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HBE |
| Device type | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-01-31 |
| Record revised | 2022-01-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Distribution end date | 2022-04-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| GP455SU | In distribution | ||
| GP576R | In distribution | ||
| GP121SU | In distribution | ||
| GP225SU | In distribution | ||
| GP126SU | In distribution | ||
| GP350SU | In distribution | ||
| GP344SU | In distribution | ||
| GP424SU | In distribution | ||
| GP304R | In distribution | ||
| GP389SU | In distribution | ||
| GP388SU | In distribution | ||
| GP204R | In distribution | ||
| GP164SU | In distribution | ||
| GP502SU | In distribution | ||
| GP501SU | In distribution | ||
| GP127R | In distribution | ||
| GP241SU | In distribution | ||
| GP128TC | In distribution | ||
| GP526R | In distribution | ||
| GP395TC-SU | In distribution | ||
| GP151SU | In distribution | ||
| GP161SU | In distribution | ||
| GP128TC-SU | In distribution | ||
| GP305R | In distribution | ||
| GP190R | In distribution | ||
| GP312SU | In distribution | ||
| GP374SU | In distribution | ||
| GP429SU | In distribution | ||
| GP230SU | In distribution | ||
| GP315SU | In distribution | ||
| US794SU | In distribution | ||
| GA810 | In distribution | ||
| GP346SU | In distribution | ||
| GP313SU | In distribution | ||
| GP147SU | In distribution | ||
| GP124SU | In distribution | ||
| GP216R | In distribution | ||
| GP120SU | In distribution | ||
| GP166SU | In distribution | ||
| GP505SU | In distribution | ||
| GP511SU | In distribution | ||
| GP236SU | In distribution | ||
| GP188R | In distribution | ||
| GP341R | In distribution | ||
| GP196R | In distribution | ||
| GP158R | In distribution | ||
| GP393R | In distribution | ||
| GP242SU | In distribution | ||
| GP115SU | In distribution | ||
| GP155R | In distribution | ||
| GP195SU | In distribution | ||
| GP447SU | In distribution | ||
| GP356SU | In distribution | ||
| GP112SU | In distribution | ||
| GP329SU | In distribution | ||
| GP495SU | 5 | In distribution | |
| GP128SU | In distribution | ||
| GP367R | In distribution | ||
| GP565SU | In distribution | ||
| GP567SU | In distribution | ||
| GP444SU | In distribution | ||
| GP339SU | In distribution | ||
| GP515SU | In distribution | ||
| GP522R | In distribution | ||
| GP229SU | In distribution | ||
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| GP122R | In distribution | ||
| GP330SU | In distribution | ||
| US771SU | In distribution | ||
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| GP202SU | In distribution | ||
| GP124TC-SU | In distribution | ||
| GP215SU | In distribution | ||
| GP308SU | In distribution | ||
| GP345SU | In distribution | ||
| GP129TC-SU | In distribution | ||
| GP336SU | In distribution | ||
| GP363SU | In distribution | ||
| US792SU | In distribution | ||
| GP352R | In distribution | ||
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| GP304TC | In distribution | ||
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| GP210TC | In distribution | ||
| GP306TC | In distribution | ||
| GP219SU | In distribution | ||
| GP364SU | In distribution | ||
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| GP367SU | In distribution | ||
| GP497SU | 5 | In distribution | |
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| GP542SU | 5 | In distribution | |
| GP373SU | In distribution | ||
| GP397R | In distribution | ||
| GP129SU | In distribution | ||
| GP382R | In distribution | ||
| GP303SU | In distribution | ||
| GP345R | In distribution | ||
| GP145R | In distribution | ||
| GP135SU | In distribution | ||
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| GP457SU | In distribution | ||
| GP176SU | In distribution | ||
| GP550SU | In distribution | ||
| GP362SU | In distribution | ||
| GP528R | In distribution | ||
| GP342SU | In distribution | ||
| GP524SU | In distribution | ||
| GP440SU | In distribution | ||
| GP147R | In distribution | ||
| GP504SU | In distribution | ||
| GP302TC | In distribution | ||
| GP399TC-SU | In distribution | ||
| GP449SU | In distribution | ||
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| GP530R | In distribution | ||
| GP337SU | In distribution | ||
| GP226R | In distribution | ||
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| GP559R | In distribution | ||
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| GP309R | In distribution | ||
| US781SU | In distribution | ||
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| GP357SU | In distribution | ||
| GP494SU | 5 | In distribution | |
| GP316SU | In distribution | ||
| GP434SU | In distribution | ||
| GP435SU | In distribution | ||
| GP367TC-SU | In distribution | ||
| GP558SU | In distribution | ||
| GP557SU | In distribution | ||
| GP242R | In distribution | ||
| GP187SU | In distribution | ||
| GP307TC-SU | In distribution | ||
| US829SU | In distribution | ||
| GP492SU | 5 | In distribution | |
| GP136R | In distribution | ||
| GP397SU | In distribution | ||
| GP527R | In distribution | ||
| GP162SU | In distribution | ||
| GP392SU | In distribution | ||
| GP432SU | In distribution | ||
| GP113TC-SU | In distribution | ||
| GP529SU | In distribution | ||
| GP363R | In distribution | ||
| GP342R | In distribution | ||
| GP341SU | In distribution | ||
| GP378SU | In distribution | ||
| GP324SU | In distribution | ||
| GP203SU | In distribution | ||
| GP427SU | In distribution | ||
| GP348R | In distribution | ||
| GP213SU | In distribution | ||
| GP184SU | In distribution | ||
| GP448SU | In distribution | ||
| GP562SU | In distribution | ||
| GP537SU | In distribution | ||
| GP314SU | In distribution | ||
| US779SU | In distribution | ||
| GP185SU | In distribution | ||
| GP551SU | In distribution | ||
| GP561SU | In distribution | ||
| GP302R | In distribution | ||
| GP123SU | In distribution | ||
| GP149SU | In distribution | ||
| GP129TC | In distribution | ||
| GP442SU | In distribution | ||
| GP496SU | 5 | In distribution | |
| GP220SU | In distribution | ||
| US774SU | In distribution | ||
| GP514SU | In distribution | ||
| GP384SU | In distribution | ||
| GP188SU | In distribution | ||
| GP532SU | In distribution | ||
| GP190SU | In distribution | ||
| GP125SU | In distribution | ||
| GP393SU | In distribution | ||
| GP175SU | In distribution | ||
| GP158SU | In distribution | ||
| GP335SU | In distribution | ||
| GP306TC-SU | In distribution | ||
| GP516SU | In distribution | ||
| GP343R | In distribution | ||
| GP532R | In distribution | ||
| GP430SU | In distribution | ||
| US861SU | In distribution | ||
| GP134SU | In distribution | ||
| GP170SU | In distribution | ||
| GP240SU | In distribution | ||
| GP127SU | In distribution | ||
| GP146SU | In distribution | ||
| GP210SU | In distribution | ||
| GP220R | In distribution | ||
| GP307TC | In distribution | ||
| GP232R | In distribution | ||
| GP445SU | In distribution | ||
| GP454SU | In distribution | ||
| GP364R | In distribution | ||
| GP328SU | In distribution | ||
| GP527SU | In distribution | ||
| GP311SU | In distribution | ||
| GP538SU | In distribution | ||
| GP353SU | In distribution | ||
| GP340SU | In distribution | ||
| GP210R | In distribution | ||
| GP201SU | In distribution | ||
| GP133R | In distribution | ||
| GP226SU | In distribution | ||
| GP194SU | In distribution | ||
| GP302SU | In distribution | ||
| GP143SU | In distribution | ||
| GP348SU | In distribution | ||
| GP375SU | In distribution | ||
| GP357R | In distribution | ||
| GP218SU | In distribution | ||
| GP122SU | In distribution | ||
| GP214R | In distribution | ||
| GP351SU | In distribution | ||
| GP209SU | In distribution | ||
| GP535SU | In distribution | ||
| GP544SU | 5 | In distribution | |
| GP163SU | In distribution | ||
| GP211R | In distribution | ||
| GP212SU | In distribution | ||
| GA844 | In distribution | ||
| US777SU | In distribution | ||
| GP306SU | In distribution | ||
| GP382SU | In distribution | ||
| GP576SU | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Midas REX MR8 | Medtronic Powered Surgical Solutions | 1,006 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker GmbH | 948 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Synthes Gmbh | 514 |
| Zethon | Zethon Ltd | 237 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | Stryker Leibinger Gmbh & Co. KG | 220 |
| Midas Rex® | Medtronic Powered Surgical Solutions | 167 |
| HiCUT Burs | Adeor Medical AG | 90 |
| Phasor | Phasor Health, LLC | 80 |
| Traumaone System | Biomet Microfixation | 62 |
| Midas REX Microsaws | Medtronic Powered Surgical Solutions | 60 |
| Mids REX MR8 | Medtronic Powered Surgical Solutions | 59 |
| Midas Rex MR8 | Medtronic PS Medical | 59 |
Showing 12 of 269. All products under Drills, Burrs, Trephines & Accessories (Simple, Powered)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203739 | 2021-08-24 |
| K183203 | 2019-08-09 |
| K182527 | 2019-01-19 |
| K172709 | 2018-10-17 |
| K022942 | 2002-10-21 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-09-05 | Class II | No Marketing Application | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | 6211 | 2019-09-20 |
| 2017-09-05 | Class II | No Marketing Application | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | 10984 | 2019-09-20 |
| 2017-09-05 | Class II | No Marketing Application | ELAN 4 burr/blade accessories were marketed without 510(k) premarket notification clearance. | 6211 | 2019-09-20 |
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.