FDA.report

PolyLock

Primary DI
00840124500754
Brand
PolyLock
Company
FUSION ORTHOPEDICS, LLC
Model
CD-SB-1520
Catalog number
CD-SB-1520
Device description
Calibrated Solid Overdrill SB 2.0mm
Published
2020-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840124500754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840124500754008401245007548401245007540840124500754

GMDN Terms

TermDefinition
Cannulated surgical drill bit, single-use, non-sterileA non-sterile metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080307067
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840124525429FuzeFix Max FTFX-FT-2544-SFX-FT-2544-S2026-02-17
00840124525436FuzeFix Max FTFX-FT-2546-SFX-FT-2546-S2026-02-17
00840124525443FuzeFix Max FTFX-FT-2548-SFX-FT-2548-S2026-02-17
00840124525320FuzeFix MiniTN-FX-6012TN-FX-60122026-02-03
00840124525337FuzeFix MiniTN-FX-6013TN-FX-60132026-02-03
00840124525344Metalogix RevolutionTN-TR-0095TN-TR-00952026-02-03
00840124525351Metalogix RevolutionTN-TR-0094TN-TR-00942026-02-03
00840124525368Metalogix RevolutionTN-TR-0090TN-TR-00902026-02-03
00840124525245FuzeFix MiniTN-FX-6011TN-FX-60112026-01-22
00840124525252Metalogix RevolutionTN-TR-0091TN-TR-00912026-01-22
00840124525269Metalogix RevolutionMX-RP-0120MX-RP-01202026-01-22
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