510(k) K993099 ยท JEC Component, Traction, Invasive
BREMER HALO SYSTEM TITANIUM SKULL PIN
| Applicant | Depuyacromed, Raynham MA, US |
| Decision | Substantially Equivalent, Dec 15, 1999 |
| Received | Sep 16, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993099
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2006 | DePuy Spine, Inc. DePuy Spine Bremer 3-D Halo Crown System
Product Code: 2923-01-100 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. 0 Degree Slider Set, DePuy Spine Bremer Halo System
Product Code: 2923-01-010 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. 12 Degree Slider Set, DePuy Spine Bremer Halo System
Product Code: 2923-01-020 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Small Halo Crown, DePuy Spine Bremer Halo System
Product Number: HT025 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Large Halo Crown, DePuy Spine Bremer Halo System
Product Number: HT026 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System
Product Code: HT025HI Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System
Product Number: HT026HI Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System
Product Code: HT001 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System
Product Code: HT002 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Small Pediatric Ring, DePuy Spine Bremer Halo System
Product Code: PT001 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Large Pediatric Ring, DePuy Spine Bremer Halo System
Product Code: PT002 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Standard Skull Rings, DePuy Spine Bremer Halo System
Product Code: AC007 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Skull pins w/Torque, DePuy Spine Bremer Halo System
Product Code: AC014 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. Extra Long Skull Pins, DePuy Spine Bremer Halo System
Product Number: AC018 Terminated |
HWC | None listed |
| Nov 2, 2006 | DePuy Spine, Inc. HI Fix Skull Pins, DePuy Spine Bremer Halo System
Product Code: AC020 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.