FDA 510(k)

SDS 成长棒

K号: K251961 · 2026-01-15

决定日期2026-01-15

产品代码PGM

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

SDS Growing Rod is the device name listed in this FDA 510(k) record. The listed applicant is BAAT Medical Products B.V.. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K251961. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SDS Growing Rod?

SDS Growing Rod is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is BAAT Medical Products B.V.. The 510(k) number is K251961.

When did SDS Growing Rod receive FDA 510(k) clearance?

SDS Growing Rod received FDA 510(k) clearance on 2026-01-15, under 510(k) number K251961.

Who is the listed applicant for SDS Growing Rod?

The FDA 510(k) record lists BAAT Medical Products B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDS Growing Rod?

The FDA product code for SDS Growing Rod is PGM.

列明BAAT Medical Products B.V.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254176SINEFIX K220966SINEFIX K211474Kleiner KG2系统 K201830ANSER 肱骨针

相关器械（代码：PGM）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K241816VerteGlide 脊柱生长引导系统OrthoPediatrics Corp.K213196MARVEL™ Growing RodsGlobus Medical, Inc.K193224Daytona® 小身材长骨转换套件SeaSpine Orthopedics Corporation K191212CrossOver Cross Connectors, DePuy PULSE 胸腰椎螺钉系统, EXPEDIUM 穿刺螺钉系统, EXPEDIUM SFX Cross Connectors, EXPEDIUM 脊柱系统, EXPEDIUM VERSE 脊柱系统, E-Z Link Cross Connectors, ISOLA 脊柱系统, MONARCH 脊柱系统, MOSS MIAMI 脊柱系统, TiMX 低背系统, VIPER 穿刺螺钉系统, VIPER PRIME 系统, VIPER PRIME 穿刺螺钉, VIPER SAI (骶骨-翼骨-髂骨), VIPER 系统, VIPER 2 系统, VSP 脊柱系统Medos International SARL K181068CREO® 稳定系统，REVERE® 稳定系统Globus Medical, Inc.K180227Polaris 脊柱生长系统Zimmer Biomet Spine, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。