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FDA 510(k)

ZEE TRACTION SPLINT

K-Number: K813016 · 1981-11-24

ApplicantZee Medical Products Co., Inc.
Decision Date1981-11-24
Product CodeHST
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZEE TRACTION SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Zee Medical Products Co., Inc.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813016. The device is classified under product code HST. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEE TRACTION SPLINT?

ZEE TRACTION SPLINT is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Zee Medical Products Co., Inc.. The 510(k) number is K813016.

When did ZEE TRACTION SPLINT receive FDA 510(k) clearance?

ZEE TRACTION SPLINT received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813016.

Who is the listed applicant for ZEE TRACTION SPLINT?

The FDA 510(k) record lists Zee Medical Products Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZEE TRACTION SPLINT?

The FDA product code for ZEE TRACTION SPLINT is HST.

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Other records listing Zee Medical Products Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K823501ZEE SPHYGMOMANOMETERK813156ULTRA-WIDE SAFETY SPECTACLE FRAMEK812814ZEE SURGICAL INSTRUMENTSK812564ZEE LIFE SUPPORT AIR PANTSK812342ZEE EXTRICATION DEVICEK812284ZEE ELECTRODE-GEL

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Related Devices (Code: HST)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression TableStl International, Inc.K110858LO-BAK TRAXRoland F Berthiaume, DCK984190BACK-ON-TRAC, MODEL 101BOTBack-On-Track, Inc.K872121K AND D HOME TRACTJoseph A. Kott, M.D.K870212ARTHROSCOPIC SHOULDER HOLDERDyonics, Inc.K870125EXTREMITY ELEVATOROrthopedic Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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