FDA 510(k)

IdentiTi™ II Interbody System

K-번호: K242364 · 2024-10-04

결정일2024-10-04

제품 코드MAX

자문 위원회OR

결정Substantially Equivalent

기기 요약

IdentiTi™ II Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Spine, Inc.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K242364. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the IdentiTi™ II Interbody System?

IdentiTi™ II Interbody System is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Alphatec Spine, Inc.. The 510(k) number is K242364.

When did IdentiTi™ II Interbody System receive FDA 510(k) clearance?

IdentiTi™ II Interbody System received FDA 510(k) clearance on 2024-10-04, under 510(k) number K242364.

Who is the listed applicant for IdentiTi™ II Interbody System?

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

What is the FDA product code for IdentiTi™ II Interbody System?

The FDA product code for IdentiTi™ II Interbody System is MAX.

Alphatec Spine, Inc.를 신청인으로 등재한 기타 기록

K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System K253216IntraOp Alignment System; CONTOUR3D Bending System K253615Invictus Bands System K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)K252842SafeOp 3: Neural Informatix System K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)

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