A.l.p.s.®
196 catalogue numbers from 8513-18-208, listed by Biomet Orthopedics, United States, under Plate, Fixation, Bone. 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
196catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| 510(k) | K101421 |
| Record published | 2020-07-10 |
| Record revised | 2025-11-20 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8513-18-208 | 15 HOLE LEFT 142 MM | In distribution |
| 110017640 | 3.5 mm x 40 mm | In distribution |
| 110016969 | Extended 2 Hole Large | In distribution |
| 8562-02-015 | 15 HOLE | In distribution |
| 8550-37-030 | 3.5 MM x 30 MM | In distribution |
| 8550-37-055 | 3.5 MM x 55 MM | In distribution |
| 1312-18-300 | Small 9 Hole 74 mm | In distribution |
| 110008303 | Small, Right | In distribution |
| 110017744 | 3.5 mm x 44 mm | In distribution |
| 110017628 | 3.5 mm x 28 mm | In distribution |
| 8562-04-007 | 7 HOLE | In distribution |
| 110017652 | 3.5 mm x 52 mm | In distribution |
| 110018014 | 3.5 mm x 14 mm | In distribution |
| 110016972 | Small Left | In distribution |
| 110017632 | 3.5 mm x 32 mm | In distribution |
| 8563-35-032 | 3.5 mm x 32 mm | In distribution |
| 110017918 | 3.5 mm x 18 mm | In distribution |
| 110017654 | 3.5 mm x 54 mm | In distribution |
| 8550-37-050 | 3.5 MM x 50 MM | In distribution |
| 110017944 | 3.5 mm x 44 mm | In distribution |
| 8550-37-044 | 3.5 MM x 44 MM | In distribution |
| 824077024 | 3.5 mm | In distribution |
| 824071102 | LARGE | In distribution |
| 110008295 | Large, Right | In distribution |
| 824076002 | In distribution | |
| 110017924 | 3.5 mm x 24 mm | In distribution |
| 110017922 | 3.5 mm x 22 mm | In distribution |
| 110017758 | 3.5 mm x 58 mm | In distribution |
| 110017665 | 3.5 mm x 65 mm | In distribution |
| 110017734 | 3.5 mm x 34 mm | In distribution |
| 8561-45-222 | 4.5 MM x 22 MM | In distribution |
| 8513-18-501 | In distribution | |
| 110017930 | 3.5 mm x 30 mm | In distribution |
| 110017920 | 3.5 mm x 20 mm | In distribution |
| 110017716 | 3.5 mm x 16 mm | In distribution |
| 110017754 | 3.5 mm x 54 mm | In distribution |
| 110017714 | 3.5 mm x 14 mm | In distribution |
| 824077023 | 2.5 mm | In distribution |
| 110017620 | 3.5 mm x 20 mm | In distribution |
| 110017934 | 3.5 mm x 34 mm | In distribution |
| 110017648 | 3.5 mm x 48 mm | In distribution |
| 110016968 | Extended 2 Hole Large | In distribution |
| 110016970 | Extended 3 Hole Large | In distribution |
| 110008289 | Small, Left | In distribution |
| 110017756 | 3.5 mm x 56 mm | In distribution |
| 8513-18-400 | In distribution | |
| 110018010 | 3.5 mm x 10 mm | In distribution |
| 110008271 | Extended 2 Hole Small, | In distribution |
| 110017612 | 3.5 mm x 12 mm | In distribution |
| 110008293 | Large, Left | In distribution |
| 110017956 | 3.5 mm x 56 mm | In distribution |
| 1512-20-255 | 2.5 MM | In distribution |
| 110008273 | Extended 2 Hole Large, | In distribution |
| 110018028 | 3.5 mm x 28 mm | In distribution |
| 110008315 | In distribution | |
| 1512-20-154 | 1.5 MM | In distribution |
| 8561-35-024 | 3.5 mm x 24 mm | In distribution |
| 8513-18-804 | 25 HOLE LEFT 250 MM | In distribution |
| 1512-20-311 | 1.3 MM x 11 MM | In distribution |
| 110016943 | Large | In distribution |
| 8513-18-606 | 21 HOLE 194 MM | In distribution |
| 8513-18-500 | In distribution | |
| 110017712 | 3.5 mm x 12 mm | In distribution |
| 110008299 | X-Large, Right | In distribution |
| 110018296 | X-Large, Left | In distribution |
| 110017710 | 3.5 mm x 10 mm | In distribution |
| 110017726 | 3.5 mm x 26 mm | In distribution |
| 8513-18-401 | In distribution | |
| 110008311 | In distribution | |
| 110017760 | 3.5 mm x 60 mm | In distribution |
| 110008285 | Large, Left | In distribution |
| 8561-40-046 | 4.0 mm x 46 mm | In distribution |
| 8561-45-208 | 4.5 MM x 8 MM | In distribution |
| 110017642 | 3.5 mm x 42 mm | In distribution |
| 110017638 | 3.5 mm x 38 mm | In distribution |
| 8513-18-305 | 17 HOLE RIGHT 147 MM | In distribution |
| 110017614 | 3.5 mm x 14 mm | In distribution |
| 110016967 | Extended 2 Hole Small | In distribution |
| 110017728 | 3.5 mm x 28 mm | In distribution |
| 110017960 | 3.5 mm x 60 mm | In distribution |
| 110017626 | 3.5 mm x 26 mm | In distribution |
| 1312-18-203 | Large 9 Hole 85 mm | In distribution |
| 8562-04-008 | 8 HOLE | In distribution |
| 110016966 | Extended 2 Hole Small | In distribution |
| 8561-35-065 | 3.5 mm x 65 mm | In distribution |
| 110017936 | 3.5 mm x 36 mm | In distribution |
| 110017752 | 3.5 mm x 52 mm | In distribution |
| 110008327 | 5 MM X 50 MM With | In distribution |
| 110018012 | 3.5 mm x 12 mm | In distribution |
| 110017630 | 3.5 mm x 30 mm | In distribution |
| 8563-27-024 | 2.7 MM x 24 MM | In distribution |
| 110016937 | Large | In distribution |
| 8162-07-003 | 3H | In distribution |
| 8561-40-038 | 4.0 mm x 38 mm | In distribution |
| 110017765 | 3.5 mm x 65 mm | In distribution |
| 110017916 | 3.5 mm x 16 mm | In distribution |
| 110018020 | 3.5 mm x 20 mm | In distribution |
| 8512-35-060 | 3.5 mm x 60 mm | In distribution |
| 110008333 | 12.5 MM Head | In distribution |
| 110018050 | 3.5 mm x 50 mm | In distribution |
| 110017650 | 3.5 mm x 50 mm | In distribution |
| 110017736 | 3.5 mm x 36 mm | In distribution |
| 8513-18-204 | 11 HOLE RIGHT 103 MM | In distribution |
| 110017718 | 3.5 mm x 18 mm | In distribution |
| 110017646 | 3.5 mm x 46 mm | In distribution |
| 1512-20-509 | 1.5 MM x 9 MM | In distribution |
| 1512-20-408 | 1.5 MM x 8 MM | In distribution |
| 110017910 | 3.5 mm x 10 mm | In distribution |
| 8513-18-303 | 11 HOLE LEFT 94 MM | In distribution |
| 110017940 | 3.5 mm x 40 mm | In distribution |
| 110017950 | 3.5 mm x 50 mm | In distribution |
| 110017965 | 3.5 mm x 65 mm | In distribution |
| 110017730 | 3.5 mm x 30 mm | In distribution |
| 110008279 | Extended 3 Hole Large, | In distribution |
| 110018018 | 3.5 mm x 18 mm | In distribution |
| 110016973 | Small Right | In distribution |
| 8561-35-042 | 3.5 mm x 42 mm | In distribution |
| 8512-35-032 | 3.5 mm x 32 mm | In distribution |
| 824071002 | LARGE | In distribution |
| 110017954 | 3.5 mm x 54 mm | In distribution |
| 110016974 | Large Left | In distribution |
| 8561-40-030 | 4.0 mm x 30 mm | In distribution |
| 110018297 | X-Large, Right | In distribution |
| 110017624 | 3.5 mm x 24 mm | In distribution |
| 1512-20-316 | 1.3 MM x 16 MM | In distribution |
| 8512-35-036 | 3.5 mm x 36 mm | In distribution |
| 8513-18-607 | 17 HOLE 154 MM | In distribution |
| 8561-55-040 | 5.5 MM x 40 MM | In distribution |
| 8561-55-050 | 5.5 MM x 50 MM | In distribution |
| 8562-35-008 | 8 HOLE | In distribution |
| 8563-35-018 | 3.5 mm x 18 mm | In distribution |
| 110017722 | 3.5 mm x 22 mm | In distribution |
| 110008281 | Small, Left | In distribution |
| 110008277 | Extended 3 Hole Large, | In distribution |
| 110017928 | 3.5 mm x 28 mm | In distribution |
| 110008287 | Large, Right | In distribution |
| 8563-35-046 | 3.5 mm x 46 mm | In distribution |
| 110017616 | 3.5 mm x 16 mm | In distribution |
| 110017942 | 3.5 mm x 42 mm | In distribution |
| 8561-35-020 | 3.5 mm x 20 mm | In distribution |
| 110008317 | Ø 2.7 MM | In distribution |
| 110017656 | 3.5 mm x 56 mm | In distribution |
| 110018048 | 3.5 mm x 48 mm | In distribution |
| 110017926 | 3.5 mm x 26 mm | In distribution |
| 1312-18-302 | Small 9 Hole 74 mm | In distribution |
| 110008291 | Small, Right | In distribution |
| 110018292 | Small, Left | In distribution |
| 110017610 | 3.5 mm x 10 mm | In distribution |
| 110016939 | Small | In distribution |
| 110017948 | 3.5 mm x 48 mm | In distribution |
| 8561-40-016 | 4.0 mm x 16 mm | In distribution |
| 110018293 | Small, Right | In distribution |
| 110017914 | 3.5 mm x 14 mm | In distribution |
| 8561-45-238 | 4.5 MM x 38 MM | In distribution |
| 110008275 | Extended 2 Hole Large, | In distribution |
| 8561-45-265 | 4.5 MM x 65 MM | In distribution |
| 110008297 | X-Large, Left | In distribution |
| 110017938 | 3.5 mm x 38 mm | In distribution |
| 110016971 | Extended 3 Hole Large | In distribution |
| 110017670 | 3.5 mm x 70 mm | In distribution |
| 110018295 | Large, Right | In distribution |
| 110008313 | In distribution | |
| 8561-35-046 | 3.5 mm x 46 mm | In distribution |
| 110018036 | 3.5 mm x 36 mm | In distribution |
| 110016975 | Large Right | In distribution |
| 110017952 | 3.5 mm x 52 mm | In distribution |
| 110017644 | 3.5 mm x 44 mm | In distribution |
| 110008309 | In distribution | |
| 1512-20-313 | 1.3 MM x 13 MM | In distribution |
| 110017958 | 3.5 mm x 58 mm | In distribution |
| 110008307 | Large, Right | In distribution |
| 8512-35-010 | 3.5 mm x 10 mm | In distribution |
| 110016945 | X-Large | In distribution |
| 8562-06-010 | 10 HOLE | In distribution |
| 110016941 | Small | In distribution |
| 110017658 | 3.5 mm x 58 mm | In distribution |
| 110017660 | 3.5 mm x 60 mm | In distribution |
| 110017970 | 3.5 mm x 70 mm | In distribution |
| 110017622 | 3.5 mm x 22 mm | In distribution |
| 8563-35-026 | 3.5 mm x 26 mm | In distribution |
| 110008269 | Extended 2 Hole Small, | In distribution |
| 110017636 | 3.5 mm x 36 mm | In distribution |
| 110008305 | Large, Left | In distribution |
| 110017932 | 3.5 mm x 32 mm | In distribution |
| 110008301 | Small, Left | In distribution |
| 8561-40-028 | 4.0 mm x 28 mm | In distribution |
| 110017742 | 3.5 mm x 42 mm | In distribution |
| 110008283 | Small, Right | In distribution |
| 110017912 | 3.5 mm x 12 mm | In distribution |
| 110017634 | 3.5 mm x 34 mm | In distribution |
| 110018016 | 3.5 mm x 16 mm | In distribution |
| 1312-18-500 | In distribution | |
| 110017946 | 3.5 mm x 46 mm | In distribution |
| 110017618 | 3.5 mm x 18 mm | In distribution |
| 110018220 | In distribution | |
| 110018294 | Large, Left | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243761 | 2025-02-19 |
| K022515 | 2002-09-17 |
| K020221 | 2002-04-02 |
| K013657 | 2001-12-03 |
Recalls Naming This Product
6 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | UDI-DI | 2022-02-14 | Class II | Under Investigation by firm | Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another | 12 | 2024-09-30 |
| Biomet, Inc. | 510(k) number | 2020-12-23 | Class II | Device Design | The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill. | 174 systems | 2023-04-13 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 15 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2020-05-14 | Class II | Device Design | Distributed to the field without having completed design history files or design transfer activities | 15 OUS | 2021-04-08 |
| Biomet, Inc. | 510(k) number | 2015-11-20 | Class II | Process change control | These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the s | 182, 965 | 2016-09-08 |
| Biomet, Inc. | 510(k) number | 2013-12-19 | Class II | Labeling mix-ups | 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw. | 52 | 2015-07-07 |
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.