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Trimed, INC.

Last updated September 17, 2026

Information

Country: US
Address: 27533 Avenue Hopkins, Santa Clarita, CA, 91355
Website: trimedortho.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(661)255-7406
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3001236812
DUNS Number: 138041277

Catalogue (2974)

Page 59 of 60

Device	Model / Reference	Registries	Class	Status
Tools - Screws	GRIPRHX-2.0	FDA UDI	Class I	Active
FPS Non-Locking Screw 2.7mm	CNS2.7-26	FDA UDI	Class II	Active
Tools - FPS	PLTCUTR	FDA UDI	Class I	Active
Tools - TWF	RFP-CADDY	FDA UDI	Class I	Active
Tools - HCS	CSS-SCREW3.0	FDA UDI	Class I	Active
CannCompScrew 4.5mm (SelfDrill)	S4534	FDA UDI	Class II	Active
HeadCannCompScrew 3.0mm	HL3024	FDA UDI	Class II	Active
HPS Locking Screw 2.0mm	MCLS2.0-12	FDA UDI	Class II	Active
Generic Instruments	HNDL-QUICK	FDA UDI	Class I	Active
Tools - Screws	CBS-GAUGE70	FDA UDI	Class I	Active
TriMed Threaded Intramedullary Nail System	K234040	FDA 510(k)	Class II	Active
Bactagard	K811773	FDA 510(k)	Class II	Active
TriMed ASET Foot Plating System	K192696	FDA 510(k)	Class II	Active
Hiflo-Hp	K812457	FDA 510(k)	Class II	Active
Hudson Craninal Burrs	K875224	FDA 510(k)	Class II	Active
TriMed Elbow and Forearm System	K243987	FDA 510(k)	Class II	Active
Eos Small Bone Fixation System	K112794	FDA 510(k)	Class II	Active
Bactashield	K811859	FDA 510(k)	Class II	Active
TriMed Threaded Intramedullary Nail System	K211783	FDA 510(k)	Class II	Active
TriMed Bridge Plates	K241942	FDA 510(k)	Class II	Active
Iv-Filter	K840248	FDA 510(k)	Class II	Active
TriMed Total Wrist Fusion System (Total Wrist Fusion Plate)	K251945	FDA 510(k)	Class II	Active
48 Hour Set Changes	K842399	FDA 510(k)	Class II	Active
Trimed Clavicle Fixation System	K112509	FDA 510(k)	Class II	Active
TriMed Humeral Supracondylar Fixation System	K151735	FDA 510(k)	Class II	Active
Trimed Radiocarpal Fusion System	K102785	FDA 510(k)	Class II	Active
Tri-Med Model 126 Sample Line W/Extended Life Nafi	K850746	FDA 510(k)	Class II	Active
TriMed Fusion Cup System	K250948	FDA 510(k)	Class II	Active
Omnitech Large, Trimed Compression Screw	K093676	FDA 510(k)	Class II	Active
Tri-Med 610 Capnostat Gas Analyzer	K843285	FDA 510(k)	Class II	Active
Tenodesis Cross Screw, Interference Screw, Suture Bead	K081348	FDA 510(k)	Class II	Active
TriMed® Compression Screws	K243943	FDA 510(k)	Class II	Active
Paracentesis Trays	K961863	FDA 510(k)	Class II	Active
RipCord	K251134	FDA 510(k)	Class II	Active
Viragard/Virashield	K820459	FDA 510(k)	Class II	Active
Barior	K770213	FDA 510(k)	Class II	Active
TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T-	K233863	FDA 510(k)	Class II	Active
Tbw	K010545	FDA 510(k)	Class II	Active
Tri-Med Model 112 Moisture Trap	K850745	FDA 510(k)	Class II	Active
Intravenous Filter Set	K834130	FDA 510(k)	Class II	Active
Cross.bone	K071876	FDA 510(k)	Class II	Active
TriMed Nitinol Staple System	K190166	FDA 510(k)	Class II	Active
TriMed Ripcord Device	K220650	FDA 510(k)	Class II	Active
Distal Xtremities System	K252061	FDA 510(k)	Class II	Active
Isolater Thp	K811981	FDA 510(k)	Class II	Active
Trimed Bone Plates	K060041	FDA 510(k)	Class II	Active
TriMed Wrist Fixation System 3	K222637	FDA 510(k)	Class II	Active
TriMed Ankle Fixation System	K243999	FDA 510(k)	Class II	Active
TriMed Clavicle Fixation System	K230805	FDA 510(k)	Class II	Active
Fibri-Filter 20	K813001	FDA 510(k)	Class II	Active

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FDA Recalls (18)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 19, 2024	Z-1792-2024	—	open, classified	Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Mar 19, 2024	Z-1791-2024	—	open, classified	Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Nov 28, 2023	Z-0932-2024	—	open, classified	Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
Dec 22, 2022	Z-1101-2023	—	open, classified	Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Sep 28, 2018	Z-0356-2020	—	open, classified	The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Sep 28, 2018	Z-0357-2020	—	open, classified	The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Sep 28, 2018	Z-0355-2020	—	open, classified	The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Sep 28, 2018	Z-0358-2020	—	open, classified	The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Sep 28, 2018	Z-0359-2020	—	open, classified	The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Aug 24, 2018	Z-1214-2019	—	terminated	The bone screw is shorter than the intended design specification.
Aug 24, 2018	Z-0118-2020	—	terminated	Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
Aug 15, 2018	Z-0366-2020	—	terminated	The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
Apr 16, 2018	Z-2877-2018	—	terminated	Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
Apr 13, 2018	Z-2265-2018	—	terminated	During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Apr 13, 2018	Z-2264-2018	—	terminated	During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Apr 13, 2018	Z-2263-2018	—	terminated	During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Apr 13, 2018	Z-2262-2018	—	terminated	During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Jan 11, 2018	Z-1373-2018	—	terminated	Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.