Atlas FDA

BREMER HALO SYSTEM TITANIUM SKULL PIN

FDA 510(k) clearance K993099 · decided 1999-12-15

Clearance details

K-number
K993099
Device name
BREMER HALO SYSTEM TITANIUM SKULL PIN
Applicant
Depuyacromed
Decision
Substantially Equivalent
Date received
1999-09-16
Decision date
1999-12-15
Days to decision
90 days
Clearance type
Traditional
Product code
JEC
Device class
2
Regulation number
888.3040
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Raynham, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
DePuy Spine Bremer 3-D Halo Crown System Product Code: 2923-01-100 recall (Z-0130-2007)DePuy Spine, Inc.2006-11-02
0 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-010 recall (Z-0131-2007)DePuy Spine, Inc.2006-11-02
12 Degree Slider Set, DePuy Spine Bremer Halo System Product Code: 2923-01-020 recall (Z-0132-2007)DePuy Spine, Inc.2006-11-02
Small Halo Crown, DePuy Spine Bremer Halo System Product Number: HT025 recall (Z-0133-2007)DePuy Spine, Inc.2006-11-02
Large Halo Crown, DePuy Spine Bremer Halo System Product Number: HT026 recall (Z-0134-2007)DePuy Spine, Inc.2006-11-02
Small Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Code: HT025HI recall (Z-0135-2007)DePuy Spine, Inc.2006-11-02
Large Halo Crown w/HI Skull pins, DePuy Spine Bremer Halo System Product Number: HT026HI recall (Z-0136-2007)DePuy Spine, Inc.2006-11-02
Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System Product Code: HT001 recall (Z-0137-2007)DePuy Spine, Inc.2006-11-02
Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System Product Code: HT002 recall (Z-0138-2007)DePuy Spine, Inc.2006-11-02
Small Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT001 recall (Z-0139-2007)DePuy Spine, Inc.2006-11-02
Large Pediatric Ring, DePuy Spine Bremer Halo System Product Code: PT002 recall (Z-0140-2007)DePuy Spine, Inc.2006-11-02
Standard Skull Rings, DePuy Spine Bremer Halo System Product Code: AC007 recall (Z-0141-2007)DePuy Spine, Inc.2006-11-02
Skull pins w/Torque, DePuy Spine Bremer Halo System Product Code: AC014 recall (Z-0142-2007)DePuy Spine, Inc.2006-11-02
Extra Long Skull Pins, DePuy Spine Bremer Halo System Product Number: AC018 recall (Z-0143-2007)DePuy Spine, Inc.2006-11-02
HI Fix Skull Pins, DePuy Spine Bremer Halo System Product Code: AC020 recall (Z-0144-2007)DePuy Spine, Inc.2006-11-02