Atlas FDA

WIRE & STEINMAN PINS

FDA 510(k) clearance K831005 · decided 1983-05-18

Clearance details

K-number
K831005
Device name
WIRE & STEINMAN PINS
Applicant
Kirschner Medical Corp.
Decision
Substantially Equivalent
Date received
1983-03-30
Decision date
1983-05-18
Days to decision
49 days
Clearance type
Traditional
Product code
HTY
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
DRILL PT GUIDE WIRE 3.2MMX98CM, 469360 Intended to be used as a guide pin for insertion of recall (Z-2230-2018)Zimmer Biomet, Inc.2018-06-01
DRILL PT GUIDE WIRE 2MM X 60CM; 469320 Intended to be used as a guide pin for insertion of recall (Z-2231-2018)Zimmer Biomet, Inc.2018-06-01
BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of recall (Z-2232-2018)Zimmer Biomet, Inc.2018-06-01
BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of recall (Z-2233-2018)Zimmer Biomet, Inc.2018-06-01
GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion recall (Z-2234-2018)Zimmer Biomet, Inc.2018-06-01
BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of recall (Z-2235-2018)Zimmer Biomet, Inc.2018-06-01
G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of imp recall (Z-2236-2018)Zimmer Biomet, Inc.2018-06-01
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 Intended to be used as a guide pin for insertion of imp recall (Z-2237-2018)Zimmer Biomet, Inc.2018-06-01
G-PIN 2.8BL 3.2PL 98CM 2PK; 467260 NL DRIVING GUIDE 4.4MM X 80CM; 467220 Intended to be us recall (Z-2238-2018)Zimmer Biomet, Inc.2018-06-01
BEAD TIP GD WIRE 3.0MM X 60CM; 29402 Intended to be used as a guide pin for insertion of i recall (Z-2239-2018)Zimmer Biomet, Inc.2018-06-01
3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of recall (Z-2240-2018)Zimmer Biomet, Inc.2018-06-01
RECON DRILL 6MM X 439MM; 14-443023 Intended to be used as a guide pin for insertion of imp recall (Z-2241-2018)Zimmer Biomet, Inc.2018-06-01
3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of recall (Z-2242-2018)Zimmer Biomet, Inc.2018-06-01
Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 recall (Z-0087-2017)Zimmer Biomet, Inc.2016-10-14
Various trauma and sports medicine instruments and implants. Pin, fixation, smooth. recall (Z-1822-2016)Biomet, Inc.2016-05-26