FDA.reportPublic FDA data

Sterile Spine Pedicle Screw System

Primary DI
B562772044NS0
Brand
Sterile Spine Pedicle Screw System
Company
WISHBONE MEDICAL, INC.
Model
62-2673-20
Catalog number
62-2673-20
Device description
Tulip Head Positioner
Published
2022-07-19
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

Product Codes#

Code, Name table
CodeName
KILPositioner, Socket

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KILPositioner, SocketOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B562772044NS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
062355158
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B562PKGS000100Micro Surgery KitPK-GS0001PK-GS00012024-12-30
B562PKGS000200Minor Surgery KitPK-GS0002PK-GS00022024-12-30
B56251300MDG000G10WishBone Plate & Screw System51-300-MDG000G-151-300-MDG000G-12024-01-01
B56211705310200S0Smart Correction11-705-310200S11-705-310200S2023-06-23
B56211705315200S0Smart Correction11-705-315200S11-705-315200S2023-06-23
B56211705320200S0Smart Correction11-705-320200S11-705-320200S2023-06-23
B56211705325200S0Smart Correction11-705-325200S11-705-325200S2023-06-23
B56211705330200S0Smart Correction11-705-330200S11-705-330200S2023-06-23
B56211705335200S0Smart Correction11-705-335200S11-705-335200S2023-06-23
B56211705340200S0Smart Correction11-705-340200S11-705-340200S2023-06-23
B56211705345200S0Smart Correction11-705-345200S11-705-345200S2023-06-23
B56211705350200S0Smart Correction11-705-350200S11-705-350200S2023-06-23
B56211705410200S0Smart Correction11-705-410200S11-705-410200S2023-06-23
B56211705415200S0Smart Correction11-705-415200S11-705-415200S2023-06-23
B56211705420200S0Smart Correction11-705-420200S11-705-420200S2023-06-23
B56211705425200S0Smart Correction11-705-425200S11-705-425200S2023-06-23
B56211705430200S0Smart Correction11-705-430200S11-705-430200S2023-06-23
B56211705435200S0Smart Correction11-705-435200S11-705-435200S2023-06-23
B56211705440200S0Smart Correction11-705-440200S11-705-440200S2023-06-23
B56211705445200S0Smart Correction11-705-445200S11-705-445200S2023-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974940306727endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
06974940306758endophixSuzhou Endophix Co., Ltd.KIL2026-03-03
00840277133182Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133199Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133205Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133212Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133229Innomed, Inc.INNOMED, INC.KIL2026-02-06
00840277133236Innomed, Inc.INNOMED, INC.KIL2026-02-06
06974940306680endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
06974940306697endophixSuzhou Endophix Co., Ltd.KIL2025-12-12
00840277132765Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132772Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132789Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132796Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132802Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132833Innomed, Inc.INNOMED, INC.KIL2025-09-12
00840277132734Innomed, Inc.INNOMED, INC.KIL2025-08-27
00840277132659Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132666Innomed, Inc.INNOMED, INC.KIL2025-08-11
00840277132628Innomed, Inc.INNOMED, INC.KIL2025-08-04
00840277132611Innomed, Inc.INNOMED, INC.KIL2025-07-09
00840277132406Innomed, Inc.INNOMED, INC.KIL2025-06-25
00840277132390Innomed, Inc.INNOMED, INC.KIL2025-06-17
00840277132239Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132246Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132253Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132260Innomed, Inc.INNOMED, INC.KIL2025-06-04
00840277132222Innomed, Inc.INNOMED, INC.KIL2025-06-03
00840124519190IntraLockFUSION ORTHOPEDICS, LLCKIL2025-05-14
00840277131706Innomed, Inc.INNOMED, INC.KIL2025-02-12