510(k) K970957
- Device
- OSTEONICS RESTORATION ACETABULAR RING
- Applicant
- OSTEONICS CORP.
- 510(k) number
- K970957
- Product code
- JDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-06-03
- Date received
- 1997-03-17
- Regulation
- 878.3300
- Classification name
- Mesh, Surgical, Acetabular, Hip, Prosthesis
- Medical specialty
- General & Plastic Surgery
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATE SUTTON
- Address
- 59 Rte. 17 Allendale NJ US 07401 07401
FDA Registration Numbers#
- 3036756245
- 3008744062
- 1219655
- 1220477
- 3010173425
- 3008556682
- 3008868758
- 2245304
- 1828464
- 1526534
- 1818910
- 3005061536
- 3021008900
- 2249697
- 3009973505
- 3009973336
- 3038503932
- 8043792
- 2249615
- 9613369
- 3013302242
- 3016438694
- 1450662
- 9616680
- 3033509898
- 1221053
- 1822565
- 3025603301
- 3011295718
- 3006395932
- 3002907620
- 1020279
- 3007366790
- 1643264
- 3009888740
- 1043653
- 1834331
Source Documents#
Other 510(k) Records For Product Code JDJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972760 | LINK, ACETABULAR REVISION MESH CUP | Link America, Inc. | 1997-10-22 |
| K963940 | EXETER MESH | Howmedica, Inc. | 1997-02-13 |
| K962541 | REFLECTION ACETABULAR REINFORCEMENT RINGS | Smith & Nephew Richards, Inc. | 1996-09-17 |
| K962007 | PROTRUSION CAGES | Depuy, Inc. | 1996-08-01 |
| K925883 | OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS | Osteonics Corp. | 1993-06-15 |
| K890450 | INTERMEDICS APR(TM) II FEMORAL COMPONENT | Intermedics Orthopedics | 1989-08-09 |
Legacy Summary#
summary
FDA Review#
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