510(k) K872989
- Device
- MICRINS NEEDLE HOLDER
- Applicant
- MICRINS SURGICAL, INC.
- 510(k) number
- K872989
- Product code
- HXK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-21
- Date received
- 1987-07-31
- 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
- BERNHARD TEITZ
- Address
- 325 W. Huron, Suite 411 Chicago IL US 60610 60610
FDA Registration Numbers#
- 3007389672
- 3003687489
- 3010039499
- 3023657851
- 3015156396
- 9611112
- 3030644259
- 3005440795
- 3020584246
- 2431166
- 2249529
- 8010370
- 2087382
- 3006552462
- 1421879
- 3019356409
- 1056350
- 1061124
- 3009703496
- 3007334784
- 3003038445
- 8040278
- 3012101664
- 3010041511
- 1923569
- 3009465247
- 9611827
- 3016894896
- 3003963832
- 3008797953
- 8010269
- 3006487092
- 3008338766
- 3016825318
- 8040263
- 8010733
- 9611283
- 3009888740
- 1833053
- 3005083075
- 3004111573
- 3010235355
- 1645452
- 9680718
- 3008618183
- 2027754
- 3010399422
- 3009106092
- 3006524618
- 3010055973
- 1313525
- 3009971621
- 3010220595
- 3010039400
- 1054241
- 3010699884
- 3015895045
- 1045379
- 3013273457
- 1030489
- 8010343
- 3008808049
- 3004176895
- 3005273623
- 3002808270
- 3003675041
- 3015489699
- 1032347
- 3002675176
- 3001620590
- 8010422
- 3005587147
- 3024988980
- 3004168759
- 3003526896
- 3003696170
- 3012267976
- 3008285983
- 3015451162
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 |
| K860018 | FISCHER WIRE/PIN CLAMP | Buckman Co., Inc. | 1986-02-07 |
| 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