510(k) K860018
- Device
- FISCHER WIRE/PIN CLAMP
- Applicant
- BUCKMAN CO., INC.
- 510(k) number
- K860018
- Product code
- HXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-02-07
- Date received
- 1986-01-03
- Regulation
- 888.4540
- Classification name
- Holder, Needle; Orthopedic
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID W SCHLERF
- Address
- 921 Calle Verde Martinez CA US 94553 94553
FDA Registration Numbers#
- 3002769844
- 3016096142
- 3004168759
- 9710524
- 3015487912
- 9680304
- 9610905
- 3005061536
- 8010298
- 1030489
- 9612277
- 3016894896
- 3006487092
- 9614075
- 3002808270
- 9611283
- 9680424
- 3004187715
- 3003526896
- 3035366890
- 3042034415
- 3007334784
- 3003418325
- 9680244
- 3008770707
- 3008808049
- 1422507
- 3003440305
- 3013358456
- 9616088
- 2431166
- 1643264
- 3004371426
- 9614062
- 3014314985
- 3045853999
- 3004911384
- 3010726901
- 3012267976
- 3022748632
- 1835998
- 1818910
- 3043140693
- 9611502
- 3015167917
- 8010386
- 8040373
- 3015895045
- 2249529
- 3008114965
- 1932180
- 3009703496
- 3016965929
- 3008902714
- 3009790163
- 3012656745
- 3036795921
- 3021666757
- 8041151
- 3042508254
- 1043214
- 3016825318
- 9680518
- 1066741
- 9680002
- 1123010
- 2084346
- 3008285983
- 3014610488
- 8010733
- 1057946
- 1045379
- 3002834291
- 8010732
- 3010303097
- 2087382
- 3012101664
- 1423537
- 3020584246
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HXK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890167 | HOLDER, NEEDLE | Dhason Brothers, Inc. | 1989-02-03 |
| K872989 | MICRINS NEEDLE HOLDER | Micrins Surgical, Inc. | 1987-08-21 |
| K801594 | ACE FISCHER EXTERNAL FIXATION DEVICE | Ace Orthopedic Manufacturing Co. | 1980-09-09 |
| K772388 | CONVERSE-GILLIES NEEDLE HOLDER | Edward Weck, Inc. | 1978-01-20 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases