510(k) K891408
- Device
- Modified Profile Hip Acetabular Prosthesis
- Applicant
- DEPUY, INC.
- 510(k) number
- K891408
- Product code
- JDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-06-12
- Date received
- 1989-03-14
- Regulation
- 888.4580
- Classification name
- Instrument, Surgical, Sonic And Accessory/Attachment
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WAYNE L NETHERCUTT
- Address
- P.O. Box 988 Warsaw IN US 46581 46581
FDA Registration Numbers#
- 3024490294
- 3011774865
- 3010363503
- 3015207155
- 8043792
- 3009352510
- 3005282635
- 2183449
- 3021599290
- 2243757
- 9681479
- 1450662
- 9680825
- 3002806603
- 8044015
- 3030446516
- 1424263
- 3010027944
- 3029901716
- 3030183061
- 3010462278
- 3010386387
- 1825034
- 3011300255
- 3013176080
- 3027339887
- 3012663306
- 3003933619
- 3010356635
- 3035366890
- 3017619615
- 3008868758
- 3014302784
- 3007279848
- 3041274936
Source Documents#
510(k) summary PDF not indicated by FDA
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| K031280 | ULTRA-DRIVE 3 | Biomet, Inc. | 2003-09-22 |
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| K002484 | EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL | Electro Medical Systems SA | 2000-10-04 |
| K961725 | OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION | C.L. Mcintosh & Assoc., Inc. | 1996-08-01 |