FDA 510(k)

PMT Facet Fixation System, 루밍 (PMT FFS-LX)

K-번호: K230840 · 2023-12-19

결정일2023-12-19

제품 코드MRW

결정Substantially Equivalent

기기 요약

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2023-12-19 under 510(k) number K230840. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the PMT Facet Fixation System, Lumbar (PMT FFS-LX)?

PMT Facet Fixation System, Lumbar (PMT FFS-LX) is a medical device that received FDA 510(k) clearance on 2023-12-19. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K230840.

When did PMT Facet Fixation System, Lumbar (PMT FFS-LX) receive FDA 510(k) clearance?

PMT Facet Fixation System, Lumbar (PMT FFS-LX) received FDA 510(k) clearance on 2023-12-19, under 510(k) number K230840.

Who is the listed applicant for PMT Facet Fixation System, Lumbar (PMT FFS-LX)?

The FDA 510(k) record lists Providence Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMT Facet Fixation System, Lumbar (PMT FFS-LX)?

The FDA product code for PMT Facet Fixation System, Lumbar (PMT FFS-LX) is MRW.

Providence Medical Technology, Inc.를 신청인으로 등재한 기타 기록

K261665코루스™ 나비게이션 시스템-GN K253676코루스™ 후방 척추 안정 시스템 3D (코루스™ PCSS 3D)K253190코루스-엘엑스 임플란트 K251060코러스™ 내시경 nawigation 시스템-GX K251885CAVUX facet fixation system (CAVUX FFS)과 CORUS-LX 임플란트 K241035PMT 후방 골반 안정 시스템 (PCSS)

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