510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Changzhou Biomet Medical Devices Co., Ltd.

Changzhou City Jiangsu, CN

Changzhou Biomet Medical Devices Co., Ltd. appears in FDA device records in Changzhou City Jiangsu, CN. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Changzhou Biomet Medical Devices Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30079230963007923096Changzhou Biomet Medical Devices Co., Ltd.No. 235 Chuangxin Road, Changzhou City Jiangsu 213031 CN2026and 44 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1300-2022DVR Anatomic, Model No. DVRAR. Distal Volar Radius Anatomical Plate System used for the fixation of fractures and osteotomies involving the distal radius.One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR platesClass IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain