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Cement, Bone, Vertebroplasty
FDA product code NDN · Class 2 · Orthopedic
1,446
Registered devices
4,809
Adverse events
86
Recalls
108
510(k) clearances
Devices with this code
Zavation — Zavation LLCZavation — Zavation LLCiVAS — STRYKER CORPORATIONTracker Plus Kyphoplasty System — GS Medical Co., Ltd.SYNTH™ PLUS BILATERAL — IMEDICOM CO., LTD.SYNTH™ PLUS BILATERAL — IMEDICOM CO., LTD.StabiliT Second Fracture Kit — Dfine, Inc.KYPHON ACTIVOS 10 — TEKNIMEDZavation CURVED CURETTE — Zavation LLCZavation — Zavation LLCMEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.Puncture Needle — Shanghai Kinetic Medical Co., Ltd.Tool Kit — Shanghai Kinetic Medical Co., Ltd.Osseoflex SB Steerable Balloon ( 10 ga/ 4ml) — OSSEON LLCStabiliT® — Merit Medical Systems, Inc.MEDINAUT-I(ICD System) — IMEDICOM CO., LTD.SYNTH™ PLUS — IMEDICOM CO., LTD.SYNTH™ PLUS BILATERAL — IMEDICOM CO., LTD.SYNTH™ CDS — IMEDICOM CO., LTD.KIT:BALLOON,FILLER,ACCESS,DRILL — Izi Medical Products, LLCZavation — Zavation LLCCD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.Zavation — Zavation LLCV-STRUT Vertebral Implant — Hyprevention Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-15 | TEKNIMED SAS | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
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