Atlas FDA

SINEFIX

FDA 510(k) clearance K220966 · decided 2023-03-08

Clearance details

K-number
K220966
Device name
SINEFIX
Applicant
BAAT Medical Products B.V.
Decision
Substantially Equivalent
Date received
2022-04-01
Decision date
2023-03-08
Days to decision
341 days
Clearance type
Traditional
Product code
MBI
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Hengelo, NL
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch BAAT Medical Products B.V.

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Grappler Suture Anchor System (K262047)Paragon 28, Inc.2026-08-03
AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down (K262369)Stryker Endoscopy2026-07-30
Suture Button Repair System (K261770)Skeletal Dynamics, Inc.2026-07-29
Thunderbolt System (K261632)Responsive Arthroscopy, Inc.2026-07-20
Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982) (K261968)Smith & Nephew, Inc.2026-07-09
Arthrex FiberButton (K260018)Arthrex, Inc.2026-06-26
Dione PEEK Screw System (K253130)ZheJiang Decans Medical Devices Co., Ltd.2026-05-27
Y-Knotless™ Flex Anchors (K261363)CONMED Corporation2026-05-13
Anchor with Fiber Wire and Disposable Inserter (K253027)Ortobio S.A.2026-05-06
ArthroTAK Tendon Anchor Kit (K252635)ArthroTAK, LLC2026-05-01
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line (K260921)Tigon Medical2026-04-21
Arthrex FiberTak Suture Anchor (K260561)Arthrex, Inc.2026-03-20

Recalls involving this device

No recalls on record reference this clearance.