Atlas FDA

NANO SUTURE ANCHOR

FDA 510(k) clearance K112965 · decided 2011-11-02

Clearance details

K-number
K112965
Device name
NANO SUTURE ANCHOR
Applicant
Linvatec Corporation D/B/A Conmed Linvatec
Decision
Substantially Equivalent
Date received
2011-10-05
Decision date
2011-11-02
Days to decision
28 days
Clearance type
Special
Product code
MBI
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Largo, FL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Linvatec Corporation D/B/A Conmed Linvatec

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

RecordFirmDate
"***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC recall (Z-0063-2013)Linvatec Corp. dba ConMed Linvatec2012-10-15
"***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC recall (Z-0064-2013)Linvatec Corp. dba ConMed Linvatec2012-10-15
"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVAT recall (Z-0065-2013)Linvatec Corp. dba ConMed Linvatec2012-10-15
"***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVAT recall (Z-0066-2013)Linvatec Corp. dba ConMed Linvatec2012-10-15
"***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC recall (Z-0067-2013)Linvatec Corp. dba ConMed Linvatec2012-10-15
NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reatt recall (Z-0068-2013)Linvatec Corp. dba ConMed Linvatec2012-10-15