510(k) K873067
- Device
- ACROMED BONE SCREW TAP SLEEVES
- Applicant
- BUCKMAN CO., INC.
- 510(k) number
- K873067
- Product code
- HWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-02
- Date received
- 1987-08-05
- Regulation
- 888.4540
- Classification name
- Tap, Bone
- 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#
- 3002949614
- 2031009
- 9615788
- 1221934
- 3009051471
- 3019878714
- 1061124
- 3007539489
- 9611579
- 1649379
- 3010887276
- 1032347
- 3010197239
- 9614438
- 1054986
- 3004549189
- 1836357
- 1828464
- 2031093
- 8010944
- 1818910
- 3016237080
- 1000517406
- 3009973844
- 3014314623
- 8044098
- 3015399803
- 3038195984
- 3005596514
- 1424263
- 3013540005
- 3011015572
- 1720929
- 9615013
- 3013546462
- 3006128100
- 3005819474
- 3012234585
- 3005641619
- 9614986
- 3003477135
- 3005031160
- 2183449
- 3009973336
- 3011137372
- 3015383864
- 2936485
- 9616671
- 3002719998
- 2027467
- 1833986
- 3015440604
- 8043769
- 3002808227
- 3016443334
- 3012358417
- 2249615
- 3009996260
- 3004638600
- 3004187715
- 3033509898
- 1822565
- 3003120897
- 3006215390
- 3003431869
- 3026576110
- 3015877656
- 3011024991
- 9611112
- 1825034
- 1222928
- 3008114965
- 3010388970
- 3010370500
- 3008285983
- 1834379
- 3030183061
- 2027754
- 8010935
- 3004049923
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HWX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K840735 | FEMORAL CEMENT REMOVAL INSTRUMENT | Amtech Scientific, Inc. | 1984-05-14 |
Legacy Summary#
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FDA Review#
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