1.5MM System
90 catalogue numbers from 01-8636, listed by Biomet Microfixation, United States, under Cover, Burr Hole. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
90catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Biomet Microfixation, United States |
|---|---|
| FDA product code | GXR |
| Device type | Cover, Burr Hole |
| Device class | Class 2 |
| Regulation | 21 CFR 882.5250 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K121589 |
| Record published | 2020-06-17 |
| Record revised | 2025-06-09 (version 8) |
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, expiry date |
| Distribution end date | 2020-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-8636 | In distribution | |
| 01-7309 | In distribution | |
| 01-7251 | In distribution | |
| 01-7114 | In distribution | |
| 01-7110 | In distribution | |
| SP-3224 | In distribution | |
| SP-3014 | In distribution | |
| 01-7347 | In distribution | |
| 01-7227 | In distribution | |
| 95-1505 | In distribution | |
| SP-2853 | In distribution | |
| SP-2138 | In distribution | |
| SP-3227 | In distribution | |
| SP-2336 | In distribution | |
| 91-6107X | In distribution | |
| SP-2679 | In distribution | |
| SP-3132 | In distribution | |
| SP-3314 | In distribution | |
| SP-2473 | In distribution | |
| SP-3217 | In distribution | |
| SP-2888 | In distribution | |
| SP-2892 | In distribution | |
| 01-7345 | In distribution | |
| SP-1263 | In distribution | |
| 01-8604 | In distribution | |
| 01-7047 | In distribution | |
| 01-7353 | In distribution | |
| 01-8637 | In distribution | |
| SP-3332 | In distribution | |
| SP-2887 | In distribution | |
| 01-7100 | In distribution | |
| SP-2928 | In distribution | |
| SP-3023 | In distribution | |
| 01-7206 | In distribution | |
| 99-7223 | In distribution | |
| 01-7120 | In distribution | |
| SP-2029 | In distribution | |
| 01-7048-5PK | In distribution | |
| 91-1807 | In distribution | |
| 01-7102 | In distribution | |
| 91-6106 | In distribution | |
| SP-3256 | In distribution | |
| 91-6105X | In distribution | |
| SP-2682 | In distribution | |
| 95-1507 | In distribution | |
| SP-1202 | In distribution | |
| 95-6106X | In distribution | |
| SP-3033 | In distribution | |
| 95-6107 | In distribution | |
| 99-7227 | In distribution | |
| SP-2921 | In distribution | |
| 01-7205 | In distribution | |
| 91-6107 | In distribution | |
| 01-7306 | In distribution | |
| SP-2139 | In distribution | |
| 91-6105X-50 | In distribution | |
| 01-7057 | In distribution | |
| 91-6105 | In distribution | |
| 95-1503 | In distribution | |
| SP-2136 | In distribution | |
| SP-2684 | In distribution | |
| SP-2250 | In distribution | |
| SP-2472 | Withdrawn | |
| 01-8637 | Withdrawn | |
| SP-2887 | Withdrawn | |
| SP-2905 | Withdrawn | |
| SP-2886 | Withdrawn | |
| SP-2643 | Withdrawn | |
| SP-2412 | Withdrawn | |
| 01-8678 | Withdrawn | |
| SP-2062 | Withdrawn | |
| SP-3214 | Withdrawn | |
| SP-2455 | Withdrawn | |
| SP-2884 | Withdrawn | |
| SP-2922 | Withdrawn | |
| SP-2921 | Withdrawn | |
| SP-2853 | Withdrawn | |
| SP-2281 | Withdrawn | |
| SP-3216 | Withdrawn | |
| 01-7188 | Withdrawn | |
| SP-2249 | Withdrawn | |
| 95-6106X | Withdrawn | |
| SP-3021 | Withdrawn | |
| SP-2892 | Withdrawn | |
| SP-2696 | Withdrawn | |
| SP-2187 | Withdrawn | |
| SP-3223 | Withdrawn | |
| SP-2029 | Withdrawn | |
| 01-7249 | Withdrawn | |
| 95-6105X | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioplate® | Bioplate, Inc. | 48 |
| “2.0MM” System | Biomet Microfixation | 34 |
| Cover, Burr Hole | Biomet Microfixation | 21 |
| Cover, Burr Hole | Synthes Gmbh | 14 |
| Universal Neuro 3 | Stryker Leibinger Gmbh & Co. KG | 12 |
| Cover, Burr Hole | Medtronic, Inc. | 11 |
| “1.0MM” System | Biomet Microfixation | 10 |
| Raas Cranial Plating System | Alliance Partners, LLC | 10 |
| Thinflap System | Biomet Microfixation | 7 |
| Neuro System | Biomet Microfixation | 7 |
| 1.5MM System – Craniocurve (TM) Mesh | Biomet Microfixation | 7 |
| Neuro & Craniofacial Fixation System | Inno-Health Technology Co., Ltd. | 6 |
Showing 12 of 52. All products under Cover, Burr Hole
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130309 | 2013-06-17 |
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2017-01-10 | Class II | Under Investigation by firm | The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole. | 11 | 2018-03-26 |
| Biomet Microfixation | 510(k) number | 2015-08-06 | Class II | Component change control | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. | 37 cases | 2017-10-13 |
| Biomet Microfixation | 510(k) number | 2015-08-06 | Class II | Component change control | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. | 5 units | 2017-10-13 |
| Biomet Microfixation | 510(k) number | 2010-07-28 | Not classified | Labeling mix-ups | Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold | 180 | 2011-06-24 |
| Biomet Microfixation | 510(k) number | 2010-04-26 | Not classified | Error in labeling | On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly. | 23 | 2012-04-18 |
| Biomet Microfixation | 510(k) number | 2009-10-06 | Not classified | Process control | Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw. | 831 screws | 2010-04-07 |
| Biomet Microfixation | 510(k) number | 2009-10-05 | Not classified | Process design | Biomet Microfixation is recalling 91-6103 1.5×3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw. | 91 units | 2010-12-15 |
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.