510(k) K970549
- Device
- Titanium Alloy Bone Screws
- Applicant
- AESCULAP, INC.
- 510(k) number
- K970549
- Product code
- HWC
- Decision
- Substantially Equivalent for Some Indications (SN)
- Decision date
- 1997-04-30
- Date received
- 1997-02-12
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTORIA MACKINNON
- Address
- 1000 Gateway Blvd. South San Francisco CA US 94080 94080
FDA Registration Numbers#
- 3014273424
- 3010673777
- 3005064037
- 3006563559
- 3014763043
- 3013756169
- 3010622588
- 3013194153
- 3011354099
- 9610622
- 3013700547
- 3010287737
- 2320767
- 3010400367
- 3008110533
- 3010041993
- 3010047454
- 3025318945
- 3032588003
- 2020601
- 9613910
- 1047843
- 2936485
- 2032521
- 1421101
- 3015895045
- 3038503572
- 1043653
- 3009540749
- 3008868758
- 1644408
- 2028632
- 2245304
- 2183967
- 3016669046
- 3010097171
- 3011301313
- 3022295665
- 3017980266
- 1032347
- 3010560653
- 9617083
- 1219930
- 3008729892
- 3010120148
- 3000170817
- 1220477
- 3011530718
- 3009888740
- 3003761012
- 3008583793
- 1287329
- 3010047402
- 9611274
- 3007766601
- 3015410662
- 3010273872
- 8031010
- 3017528621
- 3016261131
- 3006272282
- 3009417901
- 3021010222
- 3011580264
- 3017191784
- 3027553380
- 3015831087
- 3002806470
- 1064129
- 1036836
- 3022928161
- 3009337401
- 3011230048
- 3010887276
- 1822565
- 3004961578
- 3014644608
- 8043971
- 3007700286
Source Documents#
510(k) summary PDF not indicated by FDA
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