Guide, Drill, Ligament
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
74 adverse event reports on file
- LOCKING DRILL GUIDEJun 23, 2026MalfunctionArthrex, Inc.1220246-2026-03513
- DRILL CS 7.5Dec 13, 2022MalfunctionAap Implantate Ag3001406084-2020-00018
- EXACTECHMar 29, 2022MalfunctionExactech, Inc.1038671-2022-10020
- 2.3MM DRILL GUIDE CANNULAMar 8, 2022MalfunctionAcumed, Llc3025141-2022-00046
- INCORE LAPIDUS TARGETING GUIDE ASSEMBLY RIGHT, REUSABLEAug 10, 2020MalfunctionNextremity Solutions3009540749-2020-00022
- PIN,PASSING,DRILL TIP 2.4X381MM,STRLSep 14, 2016MalfunctionSmith & Nephew, Inc.1219602-2016-00611
- PIN,PASSING,DRILL TIP 2.4X381MM,STRLSep 14, 2016MalfunctionSmith & Nephew, Inc.1219602-2016-00609
- FLEX DRILL BITOct 7, 2015MalfunctionMicroport Orthopedics Inc.3010536692-2015-01822
- FLEX DRILL BITOct 7, 2015InjuryMicroport Orthopedics Inc.3010536692-2015-01823
- *Dec 19, 2014MalfunctionStryker4506888
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
43 firms currently registered for this product code
Apex (guangzhou) Tools & Orthopedics Company
Guangzhou Guangdong, CN
Pak Tools Surgical Instruments
Sialkot Punjab, PK
Maxmorespine
San Diego, CA, US
Arthrex, Inc.
Ave Maria, FL, US
Arthrex Manufacturing Inc.
Pendleton, SC, US
Mount Mfg
Marquette, MI, US
Innotool&greminger Ag
Erlen Thurgau, CH
Glw, Inc.
Englewood Cliffs, NJ, US
Able Medical Devices
Marquette, MI, US
Phoenix Medical Products, Inc.
MOUNTAIN CITY, TN, US
Straits Orthopaedics (mfg) Sdn Bhd
Simpang Ampat Pulau Pinang, MY
Hipp Medical Ag
Renquishausen Baden-Wurttemberg, DE
Biomet, Inc.
WARSAW, IN, US
Mikron Makina Sanayi Ve Ticaret Ltd. Sti.
Ivedik Ankara, TR
Ossio Ltd.
Caesarea Central, IL
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Tdm Co.,ltd
Gwangju, KR
Arthrex Singapore Pte Ltd.
Singapore Central Singapore, SG
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Able Medical Devices
Gwinn, MI, US
Shalby Advanced Technologies, Inc.
El Dorado Hills, CA, US
Elite Medical, Llc
Florence, AL, US
Nextcon International
Sialkot Punjab, PK
3d Instrumentation Sdn Bhd
Bukit Mertajam Pulau Pinang, MY
Tribe Medical Group
London Ontario, CA
510(k) clearances
8 clearances for this product code
- Synvasive Technology, Inc.Apr 7, 1994
K930573 · SYNVASIVE CERAMIC SUTTING BLOCK
- Physio Systems, Inc.May 21, 1991
K910712 · VILLAN (VIDEO LIFT LINK ANALYSIS)
- Baxter Healthcare CorpSep 28, 1989
K892655 · ACL DRILL GUIDE SYSTEM
- Silent Call Corp.May 19, 1989
K890445 · PERSONAL ALERT ASSIST DEVICE
- Instrument Makar, Inc.Sep 6, 1988
K882407 · BOW & ARROW DRILL GUIDE
- Pfizer, Inc.Jun 17, 1988
K881378 · PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
- Dyonics, Inc.Mar 21, 1988
K880739 · DYONICS DRILL GUIDE/ISOMETER SYSTEM
- Medmetric Corp.Nov 15, 1985
K854254 · TENSION-ISOMETER