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510(k) Data Aggregation
K Number
K961320Device Name
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
Manufacturer
BUCKMAN CO., INC.
Date Cleared
1998-06-25
(811 days)
Product Code
HWC, HRS
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BUCKMAN CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cross Medical Bone Plate System is intended for non-spinal applications only in the treatment of internal fixation of pelvic fractures.
Device Description
3.5 mm x 8 mm Bone Screw through 3.5 mm x 30 mm Bone Screw in 2 mm increments
4.0 mm x 8 mm Bone Screw through 4.0 mm x 30 mm Bone Screw in 2 mm increments
C-Plates Assorted Sizes
Device specific instrumentation is necessary for the insertion and anchoring of the CM Bone Plate System. System instrumentation includes: Plate Holder, Plate Cutter, Plate Bender, Plate Shaper, Plate Template, Drill Guide, Drill Bits, Driver Handle, Screw Taps, Screwdriver, Screw Holder, Sterilizer Case.
The implants of the new system are made from titanium alloy (6A1, 4V, ELI) and CP titanium or from 22-23-5 Stainless Steel.
The titanium bone plates are made from commercially pure titanium meeting ASTM F67-89. This material is also known as Commercially Pure Titanium (CP Ti, Grade 2). The stainless steel bone plates are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The titanium bone screws are made from the industry standard alloy Ti 6A1-4V ELI, ASTM F-136-92. The stainless steel bone screws are made from ASTM F-1314, also known as 22-23-5 Stainless Steel.
The surface of both the titanium screws and titanium plates are anodized and/or matte finished. The surface of both the stainless steel screws and stainless steel plates are matte finished.
The CP titanium plates are offered for their ease of contouring and their mechanical performance.
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K Number
K974641Device Name
FUTURELASE 3000/3002 ERBIUM LASER SYSTEM
Manufacturer
BUCKMAN CO., INC.
Date Cleared
1998-06-08
(175 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BUCKMAN CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use. For use in oral/dental procedures for the incision, ablation, vaporization and hemostasis of soft tissue.
Specific Indications for Use:
1. Gingivoplasties
2. Ginaivectomies
3. Frenectomies
4. Benign and malignant lesion removal
5. Biopsies
6. Leukoplakia
7. Fibrotomy
Device Description
Pharos Optics, Inc. offers a dental laser system known as the FutureLase zooo/goo2 Erbiurm Laser System. The device utilizes laser radiation energy produced at a frequency of 2.94น. This laser system is intended for intraoral or dental soft tissue surgery including the marginal and interdental gingiva. The FutureLase zooo/zoo2 Erbium Laser System is used to assist the dentist or oral surgeon with the following general intended use and/or specific indications for use:
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K Number
K964252Device Name
ORTHOCHUCK
Manufacturer
BUCKMAN CO., INC.
Date Cleared
1997-05-27
(215 days)
Product Code
GEY
Regulation Number
878.4820Why did this record match?
Applicant Name (Manufacturer) :
BUCKMAN CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.
Device Description
The device is a simple barrel shaped plastic outer sleeve that is designed in such a way that when it is in place over a standard ¼" metal head orthopaedic chuck, it allows the surgeon or assistant to quickly and easily insert, drive and or remove any size (up to ¼" dia.) orthopaedic bit or pin. The device eliminates the necessity to use the usual chuck key such drives ordinarily require. This feature significantly reduces the chance that a glove could be cut or pinched in the exposed metal gears of the chuck and key. Pin holes in surgical gloves have been shown to a potential source of bacterial and/or viral contamination placing patients and health care providers at risk.
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K Number
K950099Device Name
SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
Manufacturer
BUCKMAN CO., INC.
Date Cleared
1997-01-16
(737 days)
Product Code
MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
BUCKMAN CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SYNERGY™ Posterior Spinal System, when using the screws as pedicle screws, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the screws fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior approach for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the SYNERGY™ Posterior Spinal System are:
1. Degenerative Disc Disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
2. Idiopathic scoliosis.
3. Kyphotic deformities of the spine.
4. Paralytic scoliosis and/or pelvic obliquity treated in combination with anterior instrumentation.
5. Lordotic deformities of the spine.
6. Neuromuscular scoliosis associated with pelvic obliquity.
7. Vertebral fracture or dislocation.
8. Tumors.
9. Spondylolisthesis.
10. Stenosis.
11. Pseudarthrosis.
12. Unsuccessful previous attempts at spinal fusion.
Device Description
The SYNERGY™ Posterior Spinal System implants are intended to stabilize the spinal operative site during the development of a solid fusion with bone graft, and are intended to be removed after the development of a solid fusion mass. The implantable portions are made from surgical implant grade stainless steel, commercially pure titanium, and titanium alloy meeting ASTM specifications. The surgical instruments are made from 17-4, 420, 440 and 455 series stainless steels (ASTM F-899-84 and A276-91). Established medical grade plastics (Ultem and Radel) are used to construct the handles, cases, etc. The system is made up of INTEGRAL™ screws, spinal hooks, adjustable and fixed transverse connectors, closed and axial rod connectors, lateral connectors, rods, instruments, and sterilization case(s).
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K Number
K960451Device Name
WEBB-MORLEY SPINE SYSTEM
Manufacturer
BUCKMAN CO., INC.
Date Cleared
1996-04-18
(79 days)
Product Code
MNH, KWP, KWQ
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
BUCKMAN CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Reduction and stabilization of grades III & IV spondylolisthesis of the fifth lumbar to first sacral vertebral interspace only. The Webb-Morley Spine System is for temporary use and must be accompanied by the application of autogenous source bone graft only. Once solid fusion is achieved, surgical removal of the device system is recommended. Planned removal of the device occurs within one year of the original surgery in adults and within two years of reaching skeletal maturity for adolescents.
Device Description
The Webb-Morley Spine System is made from surgical implant grade Stainless steel meeting ASTM F-138-86 requirements. The Webb-Morley Spine System has the same indications for use as the recently cleared TSRH® and PLSA systems. The use of the Webb-Morley Spine System as a pedicle screw system involves screw attachment at the sacrum, the L5 vertebral pedicles, the L4 vertebral pedicles and in isolated cases, the L3 vertebral pedicles. The inclusion of additional pedicular levels may sometimes be necessary in order to reduce the spondylolisthetic deformity at L5 - S1 and maintain adequate correction. The Screws of this system are limited to L3-S1 or iliac screw fixation.
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K Number
K950999Device Name
KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
Manufacturer
BUCKMAN CO., INC.
Date Cleared
1996-01-25
(328 days)
Product Code
MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
BUCKMAN CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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