510(k) K010545

Device: TBW
Applicant: TRI-MED, INC.
510(k) number: K010545
Product code: NDL
Decision: Substantially Equivalent (SESE)
Decision date: 2001-06-06
Date received: 2001-02-23
Regulation: 888.3040
Classification name: Pin, Fixation, Smooth, Metallic
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: ROBERT J MEDOFF
Address: 159 Ku'Ukama St. Kailua, HI US 96734 96734

FDA Registration Numbers#

1423662
3016655171
1834331
3007125392
2031009
3030183061
3016759112
3013564228
3018080016
3014527928
1526534

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00842188123863	K-Wires	Trimed, INC.	2021-09-20
00842188119859	Generic Instruments	Trimed, INC.	2019-07-26
00842188109232	Washers	Trimed, INC.	2016-09-07
00842188109096	Sleds	Trimed, INC.	2016-09-07
00842188109089	Sleds	Trimed, INC.	2016-09-07
00842188109072	Sleds	Trimed, INC.	2016-09-07
00842188109065	Sleds	Trimed, INC.	2016-09-07
00842188109058	Sleds	Trimed, INC.	2016-09-07
00842188109041	Sleds	Trimed, INC.	2016-09-07

Other 510(k) Records For Product Code NDL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K010847	K'FIX	Avanta Orthopaedics, Inc.	2001-06-19

Legacy Summary#

summary

FDA Review#

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