510(k) K021788
- Device
- NBD CEMENT RESTRICTOR DEVICE
- Applicant
- NEW BUSINESS DEVELOPMENT, LLC
- 510(k) number
- K021788
- Product code
- JDK
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2002-10-04
- Date received
- 2002-05-31
- Regulation
- 878.3300
- Classification name
- Prosthesis, Hip, Cement Restrictor
- 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
- TIM B LUSBY
- Address
- 605 Industrial Ct. Woodstock GA US 30189 30189
FDA Registration Numbers#
- 1218882
- 1824199
- 3010173425
- 1220477
- 9681465
- 1834379
- 3006946276
- 3004499989
- 3005180920
- 3010163695
- 1030489
- 2242737
- 9614841
- 2183946
- 3005739886
- 3008110533
- 1226544
- 3018094310
- 3000196378
- 2249697
- 3008868758
- 2245304
- 3011795235
Source Documents#
Other 510(k) Records For Product Code JDK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210062 | Mectaplug PE II | Medacta International S.A. | 2021-04-08 |
| K061465 | KMI CEMENT RESTRICTOR IMPLANT | Kinetikos Medical, Inc. | 2006-10-05 |
| K061698 | MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR | Life Spine | 2006-07-12 |
| K060247 | LIFE SPINE CEMENT RESTRICTOR | Life Spine | 2006-05-11 |
| K060132 | SPINAL USA CEMENT RESTRICTOR SYSTEM | Spinal USA | 2006-03-16 |
| K051371 | INTERBODY INNOVATIONS CEMENT RESTRICTOR | Interbody Innovations, Llp | 2005-12-06 |
| K051836 | SKELITE RESORBABLE CEMENT RESTRICTOR | Millenium Biologix, Inc. | 2005-11-21 |
| K051607 | NOVASPINE CEMENT RESTRICTOR NSCR | Novaspine, LLC | 2005-10-07 |
| K052367 | SCIENT'X CEMENT RESTRICTOR | Scient'X | 2005-10-05 |
| K041382 | POLYGRAFT BGS; BONE GRAFT SUBSTITUTE | Osteobiologics, Inc. | 2005-06-17 |
| K050699 | MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 | Amedica Corp. | 2005-04-15 |
| K041583 | PEEK CEMENT RESTRICTOR X-BOX | Innovasis, Inc. | 2004-07-22 |
| K033953 | OPTIMESH 500E CEMENT RESTRICTOR | Spineology, Inc. | 2004-07-06 |
| K040276 | QUANTUM CEMENT RESTRICTOR | Quantum Orthopedics | 2004-04-30 |
| K030767 | FIDJI SMALL CEMENT RESTRICTOR | Spine Next SA | 2003-12-22 |
Legacy Summary#
summary
FDA Review#
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